Quality

Insmed Incorporated

Manager, Product Quality Complaint Data Analytics

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

The Manager, Product Quality Complaint Data Analytics, reports to the Director of Product Quality Complaints and is responsible for leading the governance, analytics, reporting, system support, and continuous improvement of Insmed's global Product Quality Complaint program. This role serves as the business and technical subject matter expert for complaint analytics, reporting, Veeva system enhancements, process improvements, and complaint surveillance.

The position is accountable for developing and maintaining the analytical framework used to identify product quality trends, evaluate complaint data, and support Management Review and executive decision-making. The Manager partners with Product Quality Complaints, QA Operations, Technical Operations, DSPV, Quality Systems, and Patient Services to support product quality investigations, implement system enhancements, and drive continuous process improvements.

The position will be based in Bridgewater, NJ HQ (onsite 3 days a week).

**What You'll Do:**

In this role, you’ll have the opportunity to lead the Product Quality Complaint Analytics function, including complaint analytics, reporting, metrics, trending, Veeva system support and enhancements, process improvements, and Management Review reporting.

You’ll also:

- Lead and manage the QA Sr Product Complaint Specialist, providing technical leadership, coaching, performance management, and professional development to direct reports. Establish team priorities, manage workload, allocate resources, and ensure timely completion of metrics activities and assigned projects.
- Support new product launch, and continuous improvement of Insmed's Product Quality Complaint Management process across clinical and commercial products, including complaint intake, evaluation, investigation, trending, and regulatory compliance for drug, device, and combination products.
- Establish and maintain statistical processes for complaint trending, action, and alert thresholds.
- Develop and maintain complaint analytics to support product performance monitoring, Management Review, and identification of potential quality trends.
- Support the development and implementation of automated reporting, data visualization, and other analytical tools.
- Oversee development and maintenance of KPIs and metrics supporting Product Quality Complaints Management Reviews.
- Provide technical support for signal detection activities and ensure identified quality signals are appropriately escalated through investigations, CAPAs, or product assessments, as applicable.
- Perform and/or oversee statistical analyses supporting complaint investigations, deviations, CAPAs, Management Review, and quality decision-making.
- Evaluate the effectiveness of CAPAs and quality improvements through product surveillance and trend analysis.
- Develop and maintain global surveillance procedures, work instructions, and quality system documentation related to product complaints supporting FDA, 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

**Who You Are:**

You have aminimumof a Bachelor's degree in related discipline as well as a minimum of 8 years of experience in Quality Assurance, Product Quality, Post-Market Surveillance, or Product Quality Complaint Analytics, including demonstrated experience in data analytics, metrics, reporting, and continuous improvement.

You are or also have:

- A minimum of 3 years of experience leading a highly collaborative team is required.
- Experience leading Post-Market Surveillance, Quality Engineering, or Product Quality activities in a regulated industry.
- Experience managing projects, technical staff, and cross-functional initiatives.
- Experience with complaint handling, investigations, trending, and product performance monitoring.
- Experience developing complaint metrics, statistical trending methods, and action/alert thresholds.
- Working knowledge of FDA Quality System Regulations, cGMPs, Good Documentation Practices, ISO 13485
- Experience supporting deviations, CAPAs, Management Review, and continuous process improvement.
- Experience with Veeva Vault QMS, Qlik, Minitab, or similar analytics tools, highly preferred.
- Excellent analytical, communication, organizational, and problem-solving skills.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

**WhereYou’llWork**

This is a hybrid role based out of ourBridgewater, NJ office.You’llhave theoptiontowork 2 days of the week remotely, with in-person collaborationwhen it matters most.

\#LI-hybrid

\#LI-EG1

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

New Jersey

Specialist, Quality CMC Operations

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

Reporting to the Sr. Director, Quality CMC, the Quality Specialist will play a key role in executing QA activities for Insmed supporting Phase 1- 3 pipeline products. Specific areas of responsibility include Batch Record Review, Product Release process, CoA review, CoR generation, QA Metric monitoring, in addition to other QA related activities.

**What You'll Do:**

In this role, you’ll have the opportunity to perform batch disposition activities, including reviewing and approving batch records, certificates of analysis, and other relevant documentation for pipeline drug substance, drug product and medical devices.

You’ll also:

- Generate certificate of releases, create lots in electronic system and upload all required documents for internal and external stakeholders.
- Ensure compliance with all relevant regulations and guidelines related to pharmaceutical quality and batch disposition.
- Collaborate with cross-functional teams to resolve quality-related issues and ensure timely release of products.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality assurance and batch disposition processes.
- Develop and maintain standard operating procedures (SOPs) for batch disposition and quality assurance processes.
- Communicate with external suppliers and internal stakeholders regarding quality-related matters.
- Maintain accurate and organized records of all quality assurance and batch disposition activities.
- Participate in cross-functional projects and provide quality assurance expertise and support, as needed.
- Partner with Quality CMC team members and colleagues in other departments to increase the overall effectiveness of the Quality Assurance department and build supportive, productive relationships.

**Who You Are:**

You have aminimumof a Bachelor's degree in Chemistry, Life Science or related discipline as well as at least 3 years’ experience working in a pharmaceutical company. You are or also have:

- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
- Demontrated experience working with an electronic document management system.
- Must be knowledgeable on cGMP's and other regulatory requirements applicable to GMP product manufacturing operation and release.
- Proven experience in batch records review and product release process
- Demonstrate ability to manage projects and variable workloads.
- Must have excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Knowledge of Veeva Quality Vault system is highly desirable.

**WhereYou’llWork**

This is a hybrid role based out of ourBridgewater, NJ office.You’llhave theoptiontowork remotely most of the time, with in-person collaborationwhen it matters most.

**Travel Requirements**

This role requires occasionaldomestic/internationaltravel (approximatelyup to 10%).

\#LI-hybrid

\#LI-EG1

**Pay Range:**

$39.00-50.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Beeline Medicines

Senior Director, GCP Quality Assurance

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Senior Director, GCP Quality Assurance provides strategic leadership and operational oversight for Good Clinical Practice (GCP) Quality Assurance activities supporting the company’s clinical development programs. This role is accountable for ensuring that clinical trials are conducted, documented, and reported in compliance with applicable regulatory requirements, company policies, and global GCP standards while maintaining a continuous state of inspection readiness.

The Senior Director serves as a senior QA leader and strategic partner to Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, Biostatistics, and external service providers. The role is accountable for GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose GCP processes that embed quality by design across the clinical lifecycle.

**Work Arrangement & Location:**

**Hybrid -** This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as **Tuesday and Wednesday**. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

**Essential Duties and Responsibilities:**

- Define, implement, and continuously mature the GCP QA strategy aligned with clinical development objectives, corporate priorities, and global regulatory expectations.
- Serve as the senior GCP QA partner to Clinical Operations and cross-functional stakeholders, providing strategic guidance on GCP compliance, clinical quality risk management, and inspection readiness.
- Champion a proactive culture of quality, compliance, patient safety, data integrity, and continuous improvement across clinical programs.
- Build, lead, mentor, and develop GCP QA capability and/or external QA resources as the function scales.
- Ensure GCP processes are phase-appropriate, risk-based, compliant, scalable, and suitable for outsourced or hybrid clinical development models.
- Lead or provide senior QA oversight for the development, review, approval, implementation, and lifecycle management of GCP-related SOPs, policies, work instructions, and training materials.
- Provide senior QA oversight for GCP activities conducted internally and by CROs, investigator sites, vendors, and other service providers.
- Serve as sponsor QA counterpart to CRO QA groups and other external partner quality functions, ensuring clear standards, escalation pathways, and issue resolution.
- Lead GCP vendor qualification, risk-based audit strategy, issue escalation, performance oversight, and ongoing vendor governance using risk-based principles.
- Review, approve, and maintain QA oversight of GCP-related quality agreements, vendor oversight plans, audit plans, and CAPA commitments.
- Provide senior QA review of key clinical and regulatory documents, as appropriate, to support clinical development quality and submission readiness.
- Own the risk-based GCP audit program, including CRO audits, investigator site audits, vendor audits, TMF/eTMF audits, and system or process audits as applicable.
- Lead GCP inspection readiness, inspection conduct, response development, commitment tracking, and follow-up; serve as a primary QA contact during health authority inspections.
- Coordinate inspection preparation activities, mock inspections, inspection logistics, response development, CAPA planning, and verification of regulatory observation closure.
- Identify, assess, escalate, and proactively mitigate GCP compliance risks, including protocol deviation trends, vendor performance concerns, audit findings, and inspection readiness gaps.
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
- 12+ years of progressive GCP Quality Assurance or Clinical Quality experience within a biotech, pharmaceutical, or CRO environment, including significant leadership experience at the Director level or equivalent.
- Minimum 3 years of people management preferred.
- Deep knowledge of global GCP requirements and clinical trial oversight expectations, including ICH E6, FDA regulations, EU Clinical Trials Regulation considerations, and inspection readiness expectations.
- Experience with eTMF, clinical quality systems, and electronic GxP systems; familiarity with 21 CFR Part 11, data integrity principles, and Veeva or similar platforms preferred.
- Demonstrated experience leading or managing GCP audits and regulatory inspections, including inspection preparation, conduct, response development, CAPA oversight, and follow-up.
- Extensive experience overseeing CROs, clinical vendors, investigator sites, and other GCP service providers in outsourced or hybrid development models.
- Experience supporting late-stage, pivotal, or registrational clinical trials and related inspection readiness activities.
- Strong background in risk-based quality management, ICH E6(R3) risk-proportionate approaches, quality metrics, and inspection readiness.
- Experience building, scaling, or maturing GCP QA capabilities in lean, virtual, or growing biotechnology organizations.
- Executive presence and strong cross-functional influence
- Ability to balance compliance, patient safety, data integrity, and operational execution
- Position may require ability to travel 20%+ as needed of time or more including occasional overnight stay driven by business need.

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$266,000 - $344,000 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)