Job Description

Quality Assurance Manager - Contract - Cranbury NJ

Join the team as a Quality Assurance Manager and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

Primary Responsibilities:

The successful candidate will be required to support our viral vector drug substance manufacturing and testing facility. You will play a crucial role in ensuring compliance with quality standards and regulatory requirements while enhancing quality systems and processes. This position offers the chance to contribute to a dynamic team focused on advancing gene therapies for rare childhood diseases.

Skills & Requirements:

• Degree in biological sciences or related field; advanced degree preferred.
• Experience in biological sciences or biotechnology, particularly in cell and gene therapy.
• Knowledge of cGMPs and international regulations for drug manufacturing.
• Ability to work collaboratively in a fast-paced environment.

The Quality Assurance Manager's responsibilities will be:

• Support the transition from phase-appropriate to commercial GMP activities.
• Conduct product release activities, including batch record reviews.
• Assess and approve analytical documents such as validation protocols and stability data.
• Evaluate change controls for process and product impact.
• Act as QA reviewer/approver for development reports and product specifications.
• Identify and escalate critical compliance and quality assurance issues.
• Assist in preparation for FDA and other regulatory inspections.
• Review raw 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.
• Coordinate Annual Product Quality Reviews and other summaries.
• Support internal audits and risk assessments.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at [email protected]

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

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