Chief GCP QA & Inspection Readiness Lead

Beeline Medicines Corporation; Boston (MA); Ibrido; USD 266.000 - 344.000; Tempo pieno

Vantaggi offerti da questo lavoro

Discretionary annual bonus

Long-term incentive award

Comprehensive benefits

Descrizione del lavoro

Beeline Medicines Corporation is seeking a Senior Director, GCP Quality Assurance to lead strategic and operational GCP QA across clinical programs. You will ensure trials are conducted, documented, and reported in compliance with regulatory requirements and company policies while maintaining inspection readiness.

As a senior partner to Clinical Operations, Regulatory Affairs, and CROs, you will drive risk-based quality management, vendor oversight, audit strategy, and the maturation of

Competenze

• Education: Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
• 12+ years of progressive GCP Quality Assurance or Clinical Quality experience within biotech/pharma/CRO with senior leadership.
• Minimum 3 years of people management preferred.
• Deep knowledge of global GCP requirements (ICH E6, FDA, EU regulations) and inspection readiness.
• Experience with eTMF, clinical quality systems, and electronic GxP systems; familiarity with 21 CFR Part 11 and data integrity.
• Experience overseeing CROs, vendors, investigator sites, and other outsourced or hybrid development.
• Experience supporting late-stage pivotal/registrational trials and related inspection readiness.
• Strong background in risk-based quality management and ICH E6(R3) risk-based approaches.
• Executive presence and cross-functional influence; travel 20%+ as needed.

Mansioni

• Define, implement, and mature GCP QA strategy aligned with clinical objectives and global regulatory expectations.
• Serve as senior GCP QA partner to Clinical Operations and stakeholders on compliance and inspection readiness.
• Champion a culture of quality, patient safety, data integrity, and continuous improvement across programs.
• Build, lead, mentor, and develop GCP QA capability and external QA resources.
• Ensure GCP processes are phase-appropriate, risk-based, compliant, and scalable for outsourced or hybrid models.
• Lead the development, review, and lifecycle management of GCP SOPs, policies, and training materials.
• Provide QA oversight for CROs, investigator sites, vendors, and TMF/eTMF activities.
• Oversee vendor qualification, audit strategy, CAPA, and ongoing governance.
• Review key clinical/regulatory documents to support submissions and quality.
• Own the audit program including CRO, site, vendor, and system audits; inspection readiness.
• Coordinate inspection preparation, mock inspections, responses, and CAPA tracking.
• Identify and mitigate GCP compliance risks including deviations, vendor issues, and gaps.

Conoscenze

Leadership

GCP knowledge

Audit management

Regulatory compliance

Risk management

Vendor management

CRO oversight

Inspection readiness

Cross-functional collaboration

Executive presence

Formazione

Bachelor's degree in science

Advanced degree preferred

Strumenti

eTMF

Veeva

Descrizione del lavoro

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, 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: Bachelor’s 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.

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

$266,000 - $344,000 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. 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.

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

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