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