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 plusMinimum 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 biotechnologyFamiliarity 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