Sr Manager of QA - Contract - Cranbury, NJ
Proclinical is seeking a Sr Manager of QA to oversee quality assurance activities at a GMP viral vector drug substance manufacturing and testing facility.
Primary Responsibilities:
The successful candidate will ensure compliance with quality standards and regulatory requirements, while enhancing quality systems and processes such as validation, material control, risk management, and training.
Skills & Requirements:
- BS degree in biological sciences or related field of study. Advance degree is a plus
- Minimum 8 years of relevant experience in biological sciences or biotechnology within quality assurance, quality control, biomanufacturing, clinical and/or regulatory operations.
- Minimum 6 years of experience with Masters degree in biological sciences or biotechnology
- Familiarity with cell and gene therapy regulations.
- Knowledge of cGMPs and international regulations.
- Ability to interpret and apply regulatory compliance requirements.
- Strong communication skills.
- Ability to work in a cross-functional team in a dynamic environment.
The Sr Manager of QA's responsibilities will be:
- Support the transition from phase-appropriate to commercial GMP activities.
- Review and approve equipment, utility, and facility qualification/validation protocols.
- Conduct product release activities, including batch record reviews.
- Assess and approve analytical documents, including validation protocols and testing data.
- Evaluate change controls for risks and impacts.
- Identify and escalate critical compliance and quality assurance issues.
- Review data for internal reports and regulatory submissions.
- Collaborate with experts to improve processes and procedures.
- Approve SOPs, specifications, and controlled documents.
- Track and trend deviations and corrective actions.
- Ensure timely closure of audit observations and corrective actions.
- Support risk assessments and mitigation activities.
- Coordinate quality assurance activities during technology transfer projects.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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