Manager, Quality Assurance - GMP Operations

Role Summary

Manager, Quality Assurance - GMP Operations. Perform a variety of Quality Assurance operations activities to support commercial and clinical drug products and ensure compliance with applicable US regulatory requirements and Heron procedures. Responsible for reviewing executed batch records and final lot disposition ensuring product lots meet specifications. Provide Quality Assurance and compliance oversight to GMP contract service providers for manufacturing and analytical testing operations for sterile drug products. Collaborate with cross-functional representatives on Heron Product Teams to ensure overall compliance of drug products and ongoing assessment of service providers. Identify and evaluate compliance issues, provide recommendations, and lead compliant resolution of issues.

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 to ensure compliance and product quality.
• Review and approve change requests to ensure 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 by evaluating accuracy and completeness of lot file documents.
• 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 production records and QC testing results to determine QA disposition decisions for various product types.
• Organize/archive executed batch record documentation, manufacturing records, analytical data documentation, labeling and packaging records.
• Manage GMP QA SOPs, 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 Subject Matter Experts and contract manufacturing organizations on quality-related issues.
• Maintain and evaluate quality metrics; generate reports to support management and functional reviews.
• Assist in inspection readiness and compliance audits as required.
• Participate in intradepartmental and interdepartmental project teams as required.

Qualifications

• Minimum BA/BS in Chemistry, Life Sciences, or Chemical Engineering with 5+ years of experience in the pharmaceutical or biopharmaceutical GMP environment.
• Demonstrated understanding of cGMPs and ability to apply them with CMOs.
• Understanding of Quality principles and standards (21 CFR, ISO, GMP, ICH) with ability to apply to GMP operations internally and with 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 initiative.
• Strong communication, collaboration, and interpersonal skills with ability to influence and lead complex QA projects.
• Innovative thinker with ability to reconcile complex issues independently.
• Detail- and results-oriented, well-organized, able to manage multiple priorities.
• Ability to travel up to 10% of the time to supplier sites.

Skills

• Quality Assurance leadership
• Regulatory compliance (cGMP, FDA, ICH)
• Documentation, batch record review, and disposition
• Deviation/Investigation/CAPA management
• Contract manufacturing/CMO oversight
• Quality metrics and data analysis
• Regulatory submissions support

Education

• Bachelor‚Äôs degree in Chemistry, Life Sciences, or Chemical Engineering (required)

Additional Requirements

• Travel up to 10% of the time to supplier sites