Director - Quality Assurance - Glenmark Pharmaceuticals - Monroe

Job description
Glenmark Generics Ltd., a subsidiary of Glenmark Pharmaceuticals Ltd., is a fast-growing pharmaceutical organization ranked in the top 25 of all generics companies in the U.S. Glenmark is actively seeking a Director of Quality Assurance to make an immediate impact within the Quality Assurance team. The position will be located at Glenmark’s brand new manufacturing plant in Monroe, North Carolina, just outside of Charlotte. Reporting directly into the SVP of Quality Assurance, the ideal candidate will oversee all Quality Assurance and Quality Control activities at the Monroe plant, in addition to developing and implementing procedures that are critical for manufacturing operations.

Key Responsibilities:
Prepare Monroe facility for FDA approval of manufacturing operations at the site; identify potential compliance gaps with regulatory standards, and correct them accordingly
Develop and implement operating procedures to continually monitor compliance with cGMP, FDA, and other applicable regulatory requirements
Lead recruitment efforts to hire essential positions within the Quality Assurance and Quality Control functions; ensure new hires are properly trained to provide routine monitoring, auditing, reconciliations, product testing, and product release
Execute gap analysis for market complaints and product recalls
Budget management through preparation of revenue and Capex budget reports; perform resource planning and allocation within approved budgets

Ensure stability programs operate successfully, and confirm that any stability failures have been reported appropriately to CQA
Primary contact for queries and information requests from regulatory agencies; respond to observations, queries, and deficiencies noted in regulatory audits, creating Corrective and Preventive Action (CAPA) programs as needed
Ensure plant has adequate systems and resources for the qualification and validation of new equipment and facilities
Continually improve and maintain quality system controls to prevent major market complaints
Create strategies to reduce waste and improve efficiency of manufacturing operations

Desired Skills and Experience
Education:
Master's Degree
Experience:
15 - 18 years in the Pharmaceutical industry (with experience in formulation facilities), demonstrating a strong background in Quality Assurance and Quality Control
Management and supervisory experience, including employee training and development
Experience with regulatory inspections required
Product recall experience preferred
Knowledge and Skills:
Demonstrated knowledge of cGMP and U.S. regulatory guidelines
Internal auditing, validations and qualifications
Management and training skills
QMS
U.S. Pharmacopoeia
Market complaint management systems
Excellent communication skills

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