Sr. Director, R&D Quality and Compliance

Location: Hybrid Onsite (Cambridge, MA)

Focus: GxP Quality Oversight for Cell & Gene Therapy

Overview

Seeking a strategic leader to oversee global R&D Quality Assurance across clinical, research, and pharmacovigilance programs. This role ensures compliance with GCP, GLP, GVP, and research standards, drives inspection readiness, and fosters a culture of quality across internal teams and external partners.

Key Responsibilities

• Lead R&D QA strategy and implementation for global clinical trials and research programs
• Oversee quality systems, audit programs, and inspection readiness (FDA, EMA, MHRA)
• Partner cross-functionally to assess risks, resolve quality issues, and ensure regulatory compliance
• Guide development of audit plans, CAPAs, and quality risk management strategies
• Manage and mentor QA team; contribute to organizational strategy and culture
• Interface with CROs, vendors, and regulatory bodies to ensure alignment and excellence

Qualifications

• M.S. and 15+ years (or B.S. and 17+ years) in GLP/GCP/GVP quality and compliance
• 10+ years in leadership roles with proven success in inspections and regulatory strategy
• Deep knowledge of global GCP regulations and quality systems for cell/gene therapies
• Strong communication, strategic planning, and cross-functional leadership skills

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.