Sr. Manager, Quality Control
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Job Location:
Raleigh, WV - USA
Monthly Salary:
Not Disclosed
Posted on:
22 days ago
Vacancies:
1 Vacancy
Job Summary
At Heron we are unwavering in our commitment to improving the lives of patients. We aim to advance the therapeutic standard of care for patients through a portfolio of best-in-class therapies in Acute Care and Oncology that bring together our innovative science and technologies with well-known pharmacology to deliver medicines that matter.
We are excited to be growing and adding to our amazing team! Come join us!
POSITION: SENIOR MANAGER QUALITY CONTROL
This position is part of a team having primary responsibility for the Quality Control (QC) of compendial and non-compendial excipients drug substances in-process materials and finished drug products. This person will work internally with Quality Assurance Manufacturing Regulatory Affairs and Supply Chain to ensure timelines for product development manufacturing and regulatory filings are met.
This position is located in Cary NC (hybrid).
ESSENTIAL DUTIES & 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.
REQUIREMENTS:
- 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.
The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.
Required Experience:
Manager
Key Skills
- Laboratory Experience
- Quality Assurance
- Construction Experience
- FDA Regulations
- ISO 9001
- Assays
- Quality Systems
- Quality Control
- Quality Management
- cGMP
- QA/QC
- HACCP
About Company
At Heron, we aim to advance the therapeutic standard of care for patients through a portfolio of best-in-class therapies to deliver medicines that matter.
