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Senior Director, GMP Quality Assurance

United States

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, CMC / GMP Quality Assurance is a senior technical and operational leader responsible for providing comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for a clinical-stage biotechnology company advancing an immunology and inflammation pipeline, including assets in lupus. This role owns the GMP QA strategy for drug substance and drug product manufacturing activities conducted through a network of contract development and manufacturing organizations (CDMOs), ensuring that all manufacturing processes, analytical methods, batch disposition decisions, and regulatory filings meet the highest standards of quality and compliance. The Senior Director will serve as the primary quality interface between internal CMC Technical Operations and external manufacturing partners, and will play a pivotal role in supporting clinical and commercial readiness milestones. This position requires a seasoned quality leader capable of operating at both strategic and tactical levels, with a track record of driving GMP compliance in complex, multi-modality development environments.


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 strategic and operational GMP quality oversight for all drug substance and drug product manufacturing activities conducted through CDMO partners, encompassing both biologics and small molecule modalities.
  • Own the batch record review and disposition process, ensuring timely and thorough evaluation of executed batch records, in-process and release testing data, deviations, and investigations prior to Authorized Person or QP release.
  • Lead quality oversight of CDMO relationships, including execution of technical quality agreements, governance of joint quality meetings, performance monitoring, and escalation of compliance concerns.
  • Manage and resolve manufacturing deviations, out-of-specification (OOS) results, and out-of-trend (OOT) observations; ensure root cause investigations are scientifically rigorous and CAPA commitments are completed on schedule.
  • Serve as the primary GMP quality lead for CMC regulatory submissions, including IND amendments, IMPD updates, BLA/MAA modules, and annual product reviews; ensure all CMC documentation accurately reflects current manufacturing and control practices.
  • Oversee the GMP audit program for manufacturing partners and raw material suppliers, including risk-based audit planning, execution, report issuance, and follow-up on corrective actions to closure.
  • Collaborate with CMC Technical Operations on process development, technology transfer, scale-up activities, and manufacturing change control to ensure quality is embedded from early development through commercial readiness.
  • Develop and maintain GMP-related SOPs, quality standards, and technical guidance documents applicable to CDMO-executed manufacturing activities; ensure alignment with evolving regulatory expectations.
  • Represent CMC Quality in health authority inspections, including pre-approval inspections (PAIs); prepare inspection readiness packages and serve as a subject matter expert for manufacturing and control-related inquiries.
  • Build, lead, and develop a high-performing CMC QA team; define roles and responsibilities, set performance expectations, and create an environment that prioritizes scientific rigor, compliance integrity, and continuous improvement.
  • Perform other duties and responsibilities as assigned


Qualifications:

  • Education: Bachelor's degree required in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline; advanced degree (MS, PhD, or PharmD) strongly preferred.
  • Minimum of 12 years of progressive GMP quality assurance experience in the pharmaceutical or biotechnology industry,
  • 3 years in a senior leadership capacity overseeing CMC or manufacturing QA functions preferred.
  • Comprehensive knowledge of global GMP regulations, including FDA 21 CFR Parts 210/211, ICH Q7, Q8, Q9, Q10, Q11, EU GMP Guidelines, and Annex requirements relevant to biologics and small molecule drug development.
  • Demonstrated expertise in batch record review, disposition decision-making, OOS/OOT investigation oversight, and CAPA management in a GMP-regulated manufacturing environment.
  • Deep proficiency in CMC regulatory submissions, with direct experience authoring or reviewing IND/IMPD sections, BLA/MAA CMC modules, and responding to health authority information requests related to manufacturing and controls.
  • Strong technical foundation in both biologics (monoclonal antibodies, fusion proteins, or similar modalities) and small molecule manufacturing processes, analytical method validation, and specification development.
  • Strategic leader who can prioritize across competing CMC quality demands—balancing inspection readiness, regulatory submission timelines, and CDMO oversight—while maintaining a clear long-term vision for organizational quality maturity.
  • Proven experience leading or supporting successful FDA and/or EMA GMP inspections, including pre-approval inspections; demonstrated ability to function as a primary quality spokesperson during regulatory agency interactions.
  • Exceptional written communication skills with demonstrated ability to author and review technically precise regulatory documents, quality agreements, audit reports, deviation investigations, and executive quality summaries.
  • Strong executive presence and verbal communication skills; able to represent the company's GMP quality posture with credibility and confidence in front of health authorities, CDMO leadership, and internal senior stakeholders.

Salary Range:

The expected annual salary range for this position is listed below. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$258,000 - $275,000 USD

Benefits:

We offer a comprehensive benefits package including:

  • Medical, Dental & Vision insurance (employee premiums 100% covered by company)
  • 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge
  • Flexible work arrangements / hybrid schedule
  • Health Savings Account (HSA)

*Benefits are subject to eligibility requirements and plan terms. Additional details 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.

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