Manager, Quality Assurance - United States
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- Our company is a branded pharmaceutical company that entered the dermatology market in 2008.
- Our company is a wholly owned subsidiary of our's Laboratories, one of India's largest and most respected pharmaceutical companies.
- Our company is a fresh face in the dermatology community and will provide innovative products and solutions that meet unmet physician and patient needs.
- We also differentiate our company in our reliance on research and development, in our commitment to using input from physicians to shape our focus and future direction, and in our support of the dermatology community.
- The Quality Assurance Manager is responsible for providing leadership and Quality Assurance Management support within Proprietary Products division.
- This individual will have responsibility for Quality aspects related to Quality Systems, oversee and manage contract manufacturers, Finished Product Batch Release and Change Control.
- Oversee CMO’s to ensure products manufactured for our company are produced in accordance with regulatory requirements, NDA commitments and company requirements ·
- Conduct batch record review and release, change control review and approval, process and analytical investigations, product complaints, Annual Product Reviews, CAPA follow up etc. related to products manufactured at CMOs in compliance with company requirements.·
- Coordinate and perform for-cause, due diligence and general GMP audits of contract manufacturers, packagers, laboratories and other suppliers.·
- Write and Implement SOPs in the Propreitory products division consistent with company's ’s global systems regarding CMO’s.·
- Prepare and Review Quality Agreements, ensure Quality Agreements are implemented where required, and ensure compliance with the requirements of the Quality Agreements.·
- Participate in Quality review meetings with CMOs, track Quality metrics, identify risk areas and propose CAPAs to resolve Quality matters with external partners· Prepare and discuss quality issues with management on a monthly basis·
- Participate in FDA Inspections and customer audits as required
- B.S. or M.S. in a Chemistry, Biology, or other life science, with 8+ years of progressive experience in a pharmaceutical and/or biotech Quality manufacturing environment.·
- Strong understanding of pharmaceutical manufacturing, packaging and testing processes, and management of Quality Management Systems.·
- Thorough understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents·
- Must have prior experience in working with CMOs.·
- Excellent communication (verbal and written), strong analytical and investigative, organizational and time management skills; strong attention to detail. ·
- Excellent negotiation and influencing skills required. ·
- Travel (10-30%) between CMO and Corporate location in NJ.
Equal Opportunity Employer:
Minorities/Women/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.