Senior Director, GCP Quality Assurance

About Beeline Medicines:

Beeline Medicines is a clinicalstage 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 companys 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: Bachelors 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.

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 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