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 GMP Quality Assurance Manager manages GMP quality assurance oversight of manufacturing, testing, and supply chain activities, ensuring products are manufactured and released in compliance with applicable GMP regulations and company quality standards. Provides day-to-day quality oversight of CMO/CDMO manufacturing and testing activities, reviewing and approving batch records, deviations, CAPAs, and change controls that affect product quality. Leads or supports internal and external GMP audits, manages quality agreements with external manufacturing partners, and represents Quality during health authority inspections. This role requires strong technical GMP expertise combined with the judgment to manage quality risk across a network of external manufacturing partners.
Work Arrangement & Location:
Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.
Essential Duties and Responsibilities:
- Provide GMP quality oversight of CMO/CDMO manufacturing and testing activities for assigned products.
- Review and approve batch records, deviations, CAPAs, and change controls related to GMP manufacturing.
- Support product disposition and release activities in collaboration with Quality Control and Regulatory.
- Lead or support internal and external GMP audits, including CMO/vendor qualification audits.
- Manage quality agreements and ongoing quality oversight of external manufacturing partners.
- Support inspection readiness and represent Quality during health authority inspections.
- Perform other duties and responsibilities as assigned.
Qualifications:
- Education: Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
- 5 years of GMP quality assurance experience in the pharma/biotech industry, including CMO/vendor oversight and batch disposition.
- Experience across both biologics and small molecule modalities preferred.
- Experience supporting both clinical-stage and commercial manufacturing environments preferred.
- Strong knowledge of GMP regulations (FDA, EMA, ICH Q7/Q10) and quality management systems.
- Working knowledge of batch record review, deviation, and CAPA processes with familiarity with root cause analysis methodologies for quality events and complaints.
- Understanding of quality agreement structure and CMO/CDMO oversight requirements.
- Ability to lead audits and manage quality issues with external manufacturing partners.
- Sound quality risk-management judgment in disposition and change-control decisions.
- Strong written and verbal communication skills for interactions with CMOs/CDMOs, internal stakeholders, and health authorities.
- Ability to clearly document and communicate quality findings and corrective actions.
- Position may require ability to travel 30%+ 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.
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 [email protected] 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
Skills Required
- Bachelor's degree in a scientific or related discipline
- At least 5 years of GMP quality assurance experience in the pharmaceutical or biotechnology industry
- Experience with CMO/CDMO or vendor oversight and batch disposition
- Strong knowledge of GMP regulations, including FDA, EMA, ICH Q7, and ICH Q10
- Working knowledge of batch record review, deviations, CAPA processes, root cause analysis, and quality complaints
- Understanding of quality agreements and CMO/CDMO oversight requirements
- Ability to lead audits and manage quality issues with external manufacturing partners
- Sound quality risk-management judgment for disposition and change-control decisions
- Strong written and verbal communication skills
- Ability to document and communicate quality findings and corrective actions clearly
- Ability to travel 30% or more, including occasional overnight stays
- Advanced degree
- Experience with both biologics and small-molecule modalities
- Experience supporting clinical-stage and commercial manufacturing environments
What We Do
Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies for people living with autoimmune and inflammatory diseases. The company leverages a mechanistically-guided approach to target the underlying drivers of immune dysfunction, aiming to define new treatment paradigms and provide durable, life-changing impact for patients suffering from a broad array of devastating immune-mediated conditions to improve patient outcomes.
