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Job type: Contract

Discipline: Senior/Director & VP

Location: United States

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 j.cerchio@proclinical.com

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