Heron Therapeutics, Inc. · 2 weeks ago
Manager, Quality Assurance - GMP Operations
Cary, NC
Full-time
Hybrid
Mid, Senior Level
5+ years expHeron Therapeutics, Inc. is dedicated to improving patient lives through innovative therapies in Acute Care and Oncology. The Manager of Quality Assurance for GMP Operations will oversee compliance with regulatory requirements, review batch records, and collaborate with cross-functional teams to ensure product quality and compliance.
BiotechnologyHealth CareTherapeutics
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, 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
Qualification
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
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
Preferred
Experience with QA oversight of contract service providers is desired
Company
Heron Therapeutics, Inc.
Heron Therapeutics, Inc. (formerly A.P.
51-200 employees
H1B Sponsorship
Heron Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.17BKey Investors
Hercules CapitalRubric Capital ManagementDeep Track Capital
2025-08-08Post Ipo Equity· $52.7M
2025-08-08Post Ipo Debt· $145M
2023-07-24Post Ipo Equity· $30M
Leadership Team
Craig Collard
Chief Executive Officer
Ira Duarte
Chief Financial Officer
Recent News
2025-12-05
2025-11-04
Company data provided by crunchbase