Stratacuity: Proven Scientific Placement
Sr. Director, R&D Quality and Compliance
Stratacuity: Proven Scientific Placement, Cambridge, Massachusetts, us, 02140
Sr. Director, R&D Quality and ComplianceSr. Director, R&D Quality and Compliance Direct message the job poster from Stratacuity: Proven Scientific Placement
Ready to apply Before you do, make sure to read all the details pertaining to this job in the description below. Account Executive at Stratacuity: Proven Scientific Placement
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. 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. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionQuality Assurance and Project Management IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Stratacuity: Proven Scientific Placement by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Paid maternity leave Disability insurance Paid paternity leave Get notified about new Director of Research Development jobs in
Cambridge, MA . Vice President, Research and DevelopmentSenior Director, R&D Business DevelopmentSenior Director/Dir, Commercial Analytics & Business Insights-PHARMA Greater Boston $240,000.00-$260,000.00 6 days ago Boston, MA $200,000.00-$250,000.00 2 weeks ago Senior Director of Preclinical Research and DevelopmentSenior Director of Translational DevelopmentHead of R&D and External Innovation Communications (Sr. Director) Cambridge, MA $208,200.00-$327,140.00 3 days ago Director, Head of Global R&D CommunicationsSr. Director/Director, Translational Medicine(Global) Director of Biopharma Business Development, Oncology · Lunit US Boston, MA $290,000.00-$400,000.00 2 weeks ago Senior Director of Product Management, Research Solutions Cambridge, MA $174,500.00-$274,230.00 1 day ago Senior Research Strategy and Development OfficerHead of R&D and External Innovation Communications (Sr. Director) Cambridge, MA $208,200.00-$327,140.00 3 weeks ago Boston, MA $200,000.00-$250,000.00 3 weeks ago Director of Product Management - Protein Science Medford, MA $116,500.00-$174,800.00 6 days ago Sr. Director, Patient Advocacy and Engagement Boston, MA $250,000.00-$280,000.00 3 weeks ago Boston, MA $153,000.00-$276,000.00 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Ready to apply Before you do, make sure to read all the details pertaining to this job in the description below. Account Executive at Stratacuity: Proven Scientific Placement
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. 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. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionQuality Assurance and Project Management IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Stratacuity: Proven Scientific Placement by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Paid maternity leave Disability insurance Paid paternity leave Get notified about new Director of Research Development jobs in
Cambridge, MA . Vice President, Research and DevelopmentSenior Director, R&D Business DevelopmentSenior Director/Dir, Commercial Analytics & Business Insights-PHARMA Greater Boston $240,000.00-$260,000.00 6 days ago Boston, MA $200,000.00-$250,000.00 2 weeks ago Senior Director of Preclinical Research and DevelopmentSenior Director of Translational DevelopmentHead of R&D and External Innovation Communications (Sr. Director) Cambridge, MA $208,200.00-$327,140.00 3 days ago Director, Head of Global R&D CommunicationsSr. Director/Director, Translational Medicine(Global) Director of Biopharma Business Development, Oncology · Lunit US Boston, MA $290,000.00-$400,000.00 2 weeks ago Senior Director of Product Management, Research Solutions Cambridge, MA $174,500.00-$274,230.00 1 day ago Senior Research Strategy and Development OfficerHead of R&D and External Innovation Communications (Sr. Director) Cambridge, MA $208,200.00-$327,140.00 3 weeks ago Boston, MA $200,000.00-$250,000.00 3 weeks ago Director of Product Management - Protein Science Medford, MA $116,500.00-$174,800.00 6 days ago Sr. Director, Patient Advocacy and Engagement Boston, MA $250,000.00-$280,000.00 3 weeks ago Boston, MA $153,000.00-$276,000.00 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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