Director, GCP Quality Assurance
Listed on 2026-07-26
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Healthcare
Data Scientist, Medical Science -
Quality Assurance - QA/QC
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.
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.
The Director partners closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and external service providers to implement a risk-based quality oversight model across the clinical lifecycle. The role is accountable for GCP quality systems, vendor oversight, audits, and inspection support, and plays a critical role in embedding quality by design into clinical development programs
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
- Develop and implement the GCP QA strategy aligned with clinical development objectives and global regulatory expectations
- Serve as a key QA partner to Clinical Operations and cross-functional stakeholders on GCP compliance and quality risk management.
- Promote a strong culture of quality, compliance, and continuous improvement across clinical programs
- Oversee GCP quality systems including deviations, investigations, CAPAs, change control, documentation, and training related to clinical activities.
- Ensure GCP processes are phase-appropriate, compliant, and scalable
- Support the development, review, and approval of GCP-related SOPs, policies, and work instructions.
- Provide QA oversight for GCP activities conducted internally and by CROs, vendors, and other service providers
- Lead GCP vendor qualification, audit strategy, and ongoing oversight using risk-based principles.
- Review and approve GCP-related quality agreements and vendor oversight plans
- Plan and execute risk-based GCP audits, including CRO audits, investigator site audits, and system audits as applicable.
- Lead GCP inspection readiness activities and serve as a primary QA contact during health authority inspections.
- Coordinate inspection preparation, conduct, and follow-up, including responses to regulatory observations.
- Ensure a sustainable state of inspection…
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