Senior Director, GCP Quality Assurance

The posting, as Beeline Medicines wrote it

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, impleme

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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