Manager, Quality Assurance - GMP Operations

Role Summary

Manager, Quality Assurance - GMP Operations will lead QA activities to support commercial and clinical drug products, ensure compliance with US regulatory requirements and Heron procedures, and provide QA oversight to GMP contract service providers. The role involves reviewing batch records and final lot disposition, collaborating with cross-functional teams, and guiding issue resolution. This position is located in Cary, NC (hybrid).

Responsibilities

• 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 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 requests 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 approve 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.
• Provide assistance in inspection readiness. Assist in compliance audits as required.
• Participate in intradepartmental and interdepartmental project teams as required.

Qualifications

• 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.

Additional Requirements

• Ability to travel up to 10% of the time to supplier sites.