Senior Director of Quality - Monroe, North Carolina United States - 43068



JOB DESCRIPTION

Job #: 43068
Title: Senior Director of Quality
Job Location: Monroe, North Carolina - United States
Employment Type:
Salary: $200,000.00 - $260,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


    This is a great and established company with plenty of growth opportunities!

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

QUALIFICATIONS

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

Education:
University - Bachelor's Degree/3-4 Year Degree

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