Manager, Quality Assurance - GMP Operations
- Manage interactions with GMP contract service providers and provide GMP guidance and support to Heron Therapeutics Manufacturing, Quality Control, and other departments to resolve quality issues independently.
- Review and approve master batch records, labels, and other production documents, as needed, for contract manufacturing organization excipients, drug product, drug/device combination product, and clinical labeling operations for compliance ensuring product quality standards are met, and compliant to Heron procedures.
- Review and approve change request to ensure the proposed changes are clearly described, justified, and validated or verified as completed per the pre-approved change request.
- Review executed batch records and QC release data to determine final lot disposition decision by evaluating accuracy and completeness of lot file documents to facilitate timely batch dispositions.
- Review and approval of QC stability and test method protocols and reports.
- Lead, review, and approve deviations, investigations, CAPAs, and change records, including providing QA guidance on investigation, CAPA, and change plans.
- Lead or participate in GMP investigations for proper closure and identification of CAPAs.
- Review of executed production records and QC testing results to determine QA disposition decisions (API, excipients, drug product, drug/device combination final products, training kits, and clinical labeling batches).
- Organize/Archive executed batch record documentation, manufacturing records, analytical data documentation, labeling and packaging records.
- Manage GMP QA SOPs, including facilitate periodic review, recommend enhancements, and ensure alignment across GMP QA.
- Review data for and/or sections of regulatory submissions.
- Provide annual product quality review data collection and analysis
- Communicate/collaborate with Heron Therapeutics Subject Matter Experts and contract manufacturing organizations on quality related issues supporting Heron QA.
- Maintain and evaluate quality metrics. Generate reports as applicable to support management and functional reviews.
- Provides assistance in inspection readiness. Assist in compliance audits as required.
- Participate in intradepartmental and interdepartmental project teams as required.
- Minimum BA/BS in Chemistry, Life Sciences (Biology, Pharmacology, etc.), or Chemical Engineering with 5+ years of experience in the pharmaceutical or biopharmaceutical GMP environment required.
- Demonstrated understanding of cGMPs and ability to practically apply them internally and with CMOs.
- Proven understanding of Quality principles, industry practices, and standards (21 CFR, ISO, GMP, ICH, etc.) with demonstrated ability to apply these to GMP operations internally and CMOs.
- Experience with commercial drug product operations including aseptic manufacturing, finished goods production, and analytical testing.
- Experience with QA oversight of contract service providers is desired.
- Independent decision making with a high degree of initiative.
- Strong oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, partner with key stakeholders and lead complex QA projects.
- Innovative thinker with demonstrated ability to reconcile more complex issues independently.
- Motivated self-starter; detail, records, and results oriented.
- Well organized and efficient with ability to manage multiple priorities.
- Innovative thinker and problem solver with integrity.
- Ability to travel up to 10% of the time to supplier sites. The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
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