Fresenius Kabi USA
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Senior Manager, GxP Compliance Officer
Location
United States
Posted
178 days ago
Salary
$140K - $165K / year
Bachelor Degree8 yrs expEnglish
Job Description
• Lead, coordinate, verify and track global compliance activities within the pharmaceutical division
• Evaluate investigations and changes impacting regulatory commitments
• Identify and remediate plant quality and compliance risks
• Support plants on strategy and compliance plans for identified gaps
• Prepare manufacturing sites for US-FDA inspections, including training and mock inspections
• Direct participation and support during US-FDA inspections
• Identify new FDA cGMP trends and develop compliance strategies
• Prepare global quality management documents (e.g. SOPs)
• Collaborate on strategic goals with other corporate quality functions
• Communicate findings and risks to management
Job Requirements
- Minimum of Bachelor’s degree required
- Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable
- 8+ years of experience in pharmaceutical industry and/or US-FDA
- Thorough knowledge of cGMPs, ICH guidelines, and regulatory compliance
- Professional experience in pharmaceutical industry involving aseptic processes, validation, and risk management
- Previous experience in executing and/or managing GxP audits or inspections preferred
- Strong analytical problem-solving skills and team leadership
- Ability to manage multiple complex situations and travel frequently (domestically and internationally)
Benefits
- 401(k) plan with company contributions
- Paid vacation
- Holiday and personal days
- Employee assistance program
- Health benefits including medical, prescription drug, dental and vision coverage
