Senior GMP Quality Assurance Manager New

Beeline Medicines Corporation; Northern (KY); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Discretionary annual bonus

Long-term incentive

Comprehensive benefits package

Remote-friendly environment

Travel opportunities

Job summary

Beeline Medicines is seeking a Senior GMP Quality Assurance Manager to oversee quality assurance for manufacturing, testing, and supply chain activities. You will review batch records, deviations, CAPAs, and change controls, ensuring compliance with GMP regulations and company standards.

You will lead audits and manage quality agreements with external partners. This role requires strong GMP expertise, risk management, and the ability to travel 30%+ to support external partners and inspections

Qualifications

• 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 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.
• Position may require travel 30%+ as needed.

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.

Skills

GMP Quality Assurance

Vendor Oversight

Batch Disposition

Audit Leadership

Regulatory Compliance

Quality Risk Management

Root Cause Analysis

Documentation & Communication

Education

Bachelor’s degree in a scientific or related discipline

Advanced degree preferred

Tools

Quality Management Systems (QMS)

CAPA Process

Deviation Handling

Audit Management

Job description

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.

Salary Range

$150,000 - $194,700 USD

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

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.

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 [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.