Essential Functions:

• GxP Batch Record and Product or Program Document Review for API, Intermediate, and/or Drug Substance product: Reviewing executed batch records, product or program specific documents, deviation and change control review and approval, documenting batch review comments, and effectively working with cross functional team, may be the primary QA point of contact with CDMO.
• Product Disposition: Performing activities associated with disposition of product (e.g. document review and approval, document archival, raw data review).
• Problem Solving: Representing Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Effective, independent conflict resolution.
• Technology Transfer and Validation: May participate as a QA representative on Technology Transfer and/or Validation Teams where responsibilities include providing guidance on QA procedures and policies as well as review of documents for both internal and external transfers.
• Documentation and Reporting: Reviewing, editing, or approving controlled documents. Maintain accurate and thorough documentation of related quality activities.
• Regulatory Compliance: Ensure all disposition-related activities comply with global regulatory requirements, including FDA, EMA, ICH guidelines, and other applicable regulations.
• Cross-functional Collaboration: Work closely with global manufacturing, and external vendors to address quality issues and support product development and commercialization.
• Continuous Improvement: Drive improvements in batch record review processes and procedures by identifying gaps, recommending solutions, and implementing best practices.

Requirements:

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field. Minimum of 5+ years of experience in quality assurance, batch record review, manufacture, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry.
• Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards.
• Demonstrated experience managing batch record review and deviation resolution.
• Great organization skills and have an attention to detail.
• In-depth understanding of biologics manufacturing operations.
• Good ability to prioritize multiple assignments and changing priorities.
• Excellent problem-solving skills and the ability to manage complex investigations and root cause analyses.
• Strong written and verbal communication skills, with the ability to clearly present quality issues to cross-functional teams.