Sr Manager of QA

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.

INDCQA