Manager, Quality Assurance - GMP Operations

Role Summary

Manager, Quality Assurance - GMP Operations responsible for performing a variety of Quality Assurance operations to support commercial and clinical drug products, ensuring compliance with US regulatory requirements and Heron procedures. Review executed batch records and final lot dispositions, provide QA oversight to GMP contract service providers, and collaborate with cross-functional teams to ensure overall compliance and resolution of issues. Hybrid role based in Cary, NC.

Responsibilities

• Manage interactions with GMP contract service providers and provide GMP guidance to Heron Manufacturing, Quality Control, and other departments to resolve quality issues.
• Review and approve master batch records, labels, and production documents for contract manufacturing organizations to ensure compliance and product quality.
• Review and approve change requests to ensure changes are clearly described, justified, and validated/verified as completed.
• Review executed batch records and QC release data to determine final lot disposition, facilitating timely batch dispositions.
• Review and approve QC stability and test method protocols and reports.
• Lead, review, and approve deviations, investigations, CAPAs, and change records; provide QA guidance on investigation and change plans.
• Lead or participate in GMP investigations for proper closure and CAPA identification.
• Review production records and QC testing results to determine QA disposition decisions for API, excipients, drug products, drug/device combinations, training kits, and clinical labeling batches.
• Organize/archive batch record documentation, manufacturing records, analytical data, labeling and packaging records.
• Manage GMP QA SOPs, facilitate periodic reviews, and align across GMP QA.
• Review data for regulatory submissions.
• Provide annual product quality review data collection and analysis.
• Communicate with Heron SMEs and contract manufacturers on quality issues supporting QA.
• Maintain and evaluate quality metrics; generate reports to support management reviews.
• Assist in inspection readiness and compliance audits as required.
• Participate in intradepartmental and interdepartmental project teams.

Qualifications

• Required: BA/BS in Chemistry, Life Sciences, or Chemical Engineering with 5+ years of experience in pharmaceutical or biopharmaceutical GMP environment.
• Demonstrated understanding of cGMPs and ability to apply them with CMOs.
• Proven understanding of quality principles and standards (21 CFR, ISO, GMP, ICH) and ability to apply them 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 oral and written communication, collaboration, and interpersonal skills.
• Ability to influence others, facilitate team interactions, and lead complex QA projects.
• Innovative thinker with ability to reconcile complex issues; detail- and results-oriented; well organized with ability to manage multiple priorities.
• Ability to travel up to 10% to supplier sites.

Education

• BA/BS in Chemistry, Life Sciences (Biology, Pharmacology, etc.), or Chemical Engineering

Additional Requirements

• Location: Cary, NC (hybrid)
• Travel: Up to 10% to supplier sites