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Manager, Quality Assurance

The Manager, Quality is responsible to assist the Executive Director, Quality in maintaining GMP compliance and performing the pharmaceutical quality system activities for the review, approval and disposition of intermediates, excipients, APIs, drug substances, and drug product for use in clinical trials and commercial distribution.

Quality Assurance oversight is required in all activities related to products used in clinical trials and commercial distribution. These include document control, quality auditing and review and approval of batch production and control records, labeling and distribution, specifications, test methods, stability protocols, release and stability test results, computer and process validation protocols and reports, SOPs, deviations, corrective and preventative actions, and change control. Any lapse in Quality Assurance oversight will result in non-compliance and may lead to lot failure, recall of products and clinical trial materials, and regulatory actions.

The major functions performed in this position are as follows:
• Review and approve labeling and distribution documentation
• Review, approve and disposition intermediates, APIs, drug substances and drug products. Interact with contract manufacturing organizations and contract test laboratories and monitor and assure pharmaceutical quality system adherence.
• Review and approve release and stability test results
• Coordinate and review and approve deviations, corrective and preventative actions, and change controls.
• Coordinate and review and approve SOPs and manage document control activities
• Review and approve specifications, test methods and stability protocols
• Conduct GMP quality audits of contract manufacturing organizations and contract testing laboratories.
Qualifications Required:
Education: BS/BA (Chemistry, Biology, or other Life Science)

Experience: Minimum of five years of experience in pharmaceutical quality.

Other Requirements: Vision requirements in relation to close vision (clear vision at 20 inches or less) and have the ability to focus (ability to adjust the eye to bring an object into sharp focus).

Technical Skills Required:
Knowledge and experience in the following areas:
• Current Good Manufacturing Practices (CGMP)
• Quality systems and quality assurance concepts
• Chemistry, manufacturing and controls (CMC) sections of IND/NDA/BLA
• Pharmaceutical / Biopharmaceutical QA operations with strength in small molecules and biologics
• GMP auditing
• Negotiation and influence management

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