Associate Director, Site Quality Compliance Lead (Biotech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Associate Director, Site Quality Compliance Lead (Biotech): Managing and driving the regulatory compliance process within a cell therapy manufacturing facility with an accent on GxP standards, inspection readiness, and audit management. Focus on overseeing quality systems, mitigating risks in a sterile GMP environment, and ensuring alignment with global regulatory expectations.
Location: Bridgewater, New Jersey, United States
Salary: $168,372 - $220,988 USD
Company
is a global biotechnology company dedicated to treating and curing life-threatening diseases through advanced cell therapies.
What you will do
- Provide strategic direction for site quality compliance programs, aligning with global regulations and J&J expectations.
- Lead regulatory inspections and independent audits, including front-room and back-room coordination.
- Oversee compliance health monitoring, risk assessments, and the effectiveness of CAPAs and change controls.
- Maintain site-specific quality documents, SOPs, and the Site Master File (SMF).
- Manage resources and projects within a highly matrixed organization through influence.
- Coordinate internal audits, self-inspections, and GEMBA walk programs.
Requirements
- Bachelor’s degree in a scientific or technical discipline (advanced degree preferred).
- Minimum 12 years of GxP experience in Quality, Regulatory, or related functions.
- Minimum 5 years of leadership experience, specifically leading through influence in matrixed organizations.
- Experience in aseptic manufacturing, biologics, or advanced therapies (cell therapy).
- Deep expertise in global GxP regulations (21 CFR, ICH, EU GMP, etc.).
- Proven experience hosting regulatory inspections and conducting internal audits.
Culture & Benefits
- Comprehensive medical, dental, and vision insurance.
- 401(k) retirement plan with company match vesting on day one.
- Eight weeks of paid parental leave after three months of employment.
- Generous paid time off policy including vacation, sick time, and 11 company holidays.
- Additional benefits: FSA, HSA, life insurance, and legal assistance.
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