Sr. Manager, Quality Control

Role Summary

Senior Manager, Quality Control responsible for QC of compendial and non-compendial excipients, drug substances, in-process materials, and finished drug products. Collaborates with Quality Assurance, Manufacturing, Regulatory Affairs, and Supply Chain to ensure timelines for product development, manufacturing, and regulatory filings are met. Location: Cary, NC (hybrid).

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.

Qualifications

• 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.
• 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.

Skills

• Quality Control Operations
• GXP/cGMP Compliance
• Analytical Method Development and Validation
• Stability indicating methods and SLIM database
• Laboratory Oversight and Audit Readiness
• Data Analysis (LIMS, SLIM, JMP, MiniTab, Excel, PowerPoint)
• Cross-functional Collaboration

Education

• Bachelor’s degree in Life Sciences or related field (Biology, Chemistry, Pharmacology)

Additional Requirements

• Travel up to 5-10% as required.