Heron Therapeutics, Inc. · 2 weeks ago
Sr. Manager, Quality Control
Cary, NC
Full-time
Hybrid
Senior Level
7+ years expHeron Therapeutics, Inc. is dedicated to enhancing patient care through innovative therapies in Acute Care and Oncology. They are seeking a Senior Manager of Quality Control to oversee QC processes, manage testing laboratories, and ensure compliance with regulatory standards while collaborating with various internal departments.
BiotechnologyHealth CareTherapeutics
Responsibilities
Oversight of contract testing laboratories for quality control testing of raw materials, excipients, drug substance, devices, and drug product samples
Manage and compile QC test results for CofA review, trending and tracking of test data of Heron products for internal and external review
Define strategy for internal stability program management, initiate, author, review and approve stability protocols and reports including statistical trend analysis shelf-life determination and addressing compliance challenges
Manage development and commercial product stability programs for excipients, drug product, device, and combination drug/device drug products
Review of finished product test results, change controls, and writing and revising standard operating procedures
Review and approve contract third party analytical testing laboratories QC raw data, method validation protocols and reports for raw material and finished products and associated deviations, Out of Specification (OOS) and Out of Trend (OOT) investigations
Serve as the System Administrator for the Stability Laboratory Information Management (SLIM) database, ensuring proper data entry, study creation, and system updates
Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks to Heron products
Collaborate with contract testing laboratories and internal groups to find solutions for laboratory investigations
Contribute to annual product reviews for marketed products
Interface with R&D, CTLs, CMOs, Manufacturing, QC, QA, and Regulatory Affairs regarding stability indicating methods, testing, and results. Author stability sections to support regulatory submissions
Qualification
Required
BS in life sciences (Biology, Chemistry, Pharmacology) with 7+ years in the pharmaceutical industry including experience in Quality Control Operations or related discipline with the application of cGMPs
Possess technical knowledge related to typical Quality Control activities in the pharmaceutical and medical device industries
Experience in analytical method development, validation, optimization, and transfers
Experience in GXP compliance audits and laboratory oversight
Proficient in data analysis and software tools such as LIMS, SLIM, JMP, MiniTab, Excel, and PowerPoint
Investigational and commercial product experience is preferable
Understanding of parenteral drug product and drug/device combinations desired
Independent decision making with a high degree of initiative
Detail-oriented, well-organized and skilled in managing multiple priorities efficiently
Excellent oral and written communication skills, including in cGMP documentation
Effective interpersonal skills, relationship building, collaboration, and teamwork with internal and external partners
Excellent negotiation skills and ability to lead and manage Quality Control related projects
Travel up to 5-10% required
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