Senior Director Quality
Company: Cameron Craig Group
Location: Monroe
Posted on: January 10, 2022
Job Description:
Position Summary:
We are actively seeking a Director of Quality Assurance to make an
immediate impact within the Quality Assurance team. The position
will be located at company's brand-new manufacturing plant just
outside of Charlotte, NC. Reporting directly into the SVP of
Quality Assurance, the ideal candidate will oversee all Quality
Assurance and Quality Control activities at the plant, in addition
to developing and implementing procedures that are critical for
manufacturing operations.
Key Responsibilities:
- Prepare 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
Position Requirements:
Education:
- Bachelor's degree in Biology, Chemistry, Pharmacy, or other
related scientific field
- Master's Degree preferred
Experience:
- 15+ 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
Keywords: Cameron Craig Group, Rock Hill , Senior Director Quality, Executive , Monroe, South Carolina
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