Beeline Medicines

Director, GCP Quality Assurance

Boston, Massachusetts, United States · Director

Sponsorship not specified$220k-$284kDetected 4 days ago

GCPClinical TrialsFDA RegulatoryPharmacovigilanceLeadershipGxPRegulatory Affairs

About the role

The Director, GCP Quality Assurance is responsible for providing strategic and operational Quality Assurance oversight for Good Clinical Practice (GCP) activities supporting the company's clinical development programs.
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.
Promote a strong culture of quality, compliance, and continuous improvement across clinical programs

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.
Support the development, review, and approval of GCP-related SOPs, policies, and work instructions.
Lead GCP vendor qualification, audit strategy, and ongoing oversight using risk-based principles.
Ensure critical-to-quality considerations are embedded in clinical trial design and execution.

10+ years of experience in GCP Quality Assurance or Clinical Quality within a biotech or pharmaceutical environment.
Strong knowledge of global GCP regulations and clinical trial oversight requirements.
Demonstrated experience supporting regulatory inspections and audits.
Experience overseeing CROs and other GCP service providers.
Experience supporting late-stage or pivotal clinical trials.
Strong background in risk-based quality management and inspection readiness.
Skilled at influencing without authority
Able to serve as a primary quality representative in regulatory agency interactions and inspections, communicating the company's quality posture with confidence and credibility.

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.
$220,000 - $284,000 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.
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
Specific benefit details applicable to your country or region will be provided during the offer process.
Benefits may include, but are not limited to:
Flexible work arrangements / hybrid schedule
Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms.

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.
This role ensures that clinical trials are conducted in compliance with applicable regulatory requirements, company policies, and global GCP standards, with a continuous state of inspection readiness.

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.
Beeline Medicines is an Equal Opportunity Employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.

This listing is sourced directly from Beeline Medicines's careers page and normalized into a canonical job model.