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Sr. Quality Assurance Manager - Compliance

Company: Avion Pharmaceuticals
Location: Alpharetta
Posted on: August 7, 2022

Job Description:

Senior Quality Assurance Manager - ComplianceJob Description
The Senior Quality Assurance Manager - Compliance is responsible for maintenance and oversight of the stability program, product specifications, customer complaints, FAR reporting, recalls, and approval of product labeling.Key Responsibilities/Essential Functions

  • Perform QA review and approval of Consumer Complaint Investigation reports.
  • Document and investigate clinical and commercial drug product complaints.
  • Write, review, and revise Standard Operating Procedures (SOPs) related to areas of responsibility, as necessary.
  • Build a culture of continuous improvement to improve quality behavior and sustain results.
  • Plan the effective use of labor and materials, and lead teams on special projects associated with the assigned area of responsibility.
  • Notify Senior Management of inspection observations, and significant quality or compliance issues which may affect the product or systems according to the requirement of the Management Notification SOP.
  • Provide oversight of the stability program and approve appropriate retest/expiration dates to finished drug product according to stability results.
  • Review and approve stability reports.
  • Review and approve all product labeling.
  • Oversee the system to review, approve, and maintain product specifications.
  • Ensure all events requiring FAR reporting's are communicated to management and submitted to applicable regulatory authorities.
  • Oversee the performance of recall activities.
    • Basic Qualifications
    • Bachelor's degree required; a Bachelor's degree in a scientific or technical field, preferred.
    • Minimum of 7 years of quality experience in a cGMP environment required. 2 years experience managing pharmaceutical quality systems, preferred.
    • 2 years of progressive management responsibility, required.
      Other Requirements
      • Thorough knowledge and understanding of cGMPs, FDA guidelines and other regulatory agency requirements.
      • Demonstrate strong critical thinking skills.
      • Demonstrate leadership skills that include motivating others, delegating, coaching and developing others in a team-oriented environment.
      • Proficient with Microsoft office applications.
      • Ability to anticipate and resolve problems with minimum negative impact on production, quality, safety, and cost.
      • Strong interpersonal and communication skills (both written and verbal) with all levels of management.
      • Strong attention to detail.

Keywords: Avion Pharmaceuticals, Alpharetta , Sr. Quality Assurance Manager - Compliance, Executive , Alpharetta, Georgia

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