Manager – Corporate Quality – Post-Market / External Quality
| Company | Ro |
|---|---|
| Location | Remote in USA, New York, NY, USA |
| Salary | $114800 – $141500 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree with a science focus (Biology, Chemistry, Biochemistry, Engineering, etc.)
- 5+ years working in post-market surveillance and supplier/vendor management
- Background in pharmaceutical or compounding pharmacy with knowledge of industry regulations (FDA 503A/B Compounding, FDA 21 CFR 210/211/820, CAP/CLIA for laboratories)
- Ability to travel up to 40% of time
- Proficiency in quality tools and methodologies
- Strong analytical skills with attention to detail and ability to think strategically and tactically
- Outstanding written and verbal communication skills
Responsibilities
- Oversee Quality Assurance for on-market products from commercialization through end of life, ensuring compliance with all relevant standards and regulations.
- Maintain Good Documentation Practices (GDP), including product specifications, formula approvals, and audit documentation.
- Manage Third-Party Testing, coordinating all ongoing testing activities, ensuring appropriate record retention of results, Certificates of Analysis, and other relevant documentation.
- Support Product, Process, and Material Validations/Qualifications by working cross-functionally with R&D and key stakeholders to ensure proper documentation and compliance.
- Assist in Developing, Implementing, and Maintaining a robust Quality Management System (QMS) as it relates to post-market quality.
- Conduct Vendor Audits to ensure partners meet quality standards and overall compliance requirements.
- Support Product Improvement Initiatives, including the development and execution of Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA) programs.
- Stay Informed on Industry Trends and Regulatory Changes to ensure continued compliance and best practices.
- Collaborate Cross-Functionally to uphold quality standards throughout the product lifecycle.
- Identify and Drive Process Improvements, implementing best practices to enhance efficiency and reduce defects.
- Utilize Quality Tools and Methodologies to optimize processes and improve product reliability.
Preferred Qualifications
- Illinois / Florida Pharmacist / Pharmacy Technician Licensure or ability to obtain, strongly preferred
- Previous Vendor and Third-Party Audit experience with certification as Quality Auditor or in Quality Management Systems a plus