Job Description

Directly and through subordinates and peers, the Director of Quality Control leads a multifunctional team comprised of Quality Control Analytical, Microbiology, Stability, Incoming Quality Control, and Technical Services for the Wilson manufacturing site.

Salary Range: $150,000-$175,000

Position is eligible to participate in an annual bonus plan with a target of 16% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Oversee the testing of all products manufactured at the Wilson Manufacturing facility. Testing performed includes chemical and microbiological for IQC, raw material, in-process and finished product testing.
• Direct the Stability program which includes the testing, data analysis and FDA submission and annual report preparation for the Wilson site.
• Direct activities associated with investigations related to cGMP manufacturing and analytical processes for Fresenius Kabi USA products.
• Direct activities associated with implementation of company wide initiatives.
• Manages the Quality Control requests during FDA site inspections in Wilson.
• Direct activities associated with evaluations of processes, results and risks.
• Drive operational efficiencies and process optimization utilizing KPIs and standard work level loading techniques.
• Drive synergies, optimize workflows, and streamline functions
• Drive development of continuous improvement plans and standards; leading teams to execute continuous improvement projects such as 5S and visual management.
• Prepare departmental budgets and capital plan and ensure adherence to budgetary goals and execution of the approved capital equipment plan.
• Direct the equipment validation and analytical equipment calibration programs. Ensure the systems are robust and compliant with current industry practice and cGMP requirements.
• Lead the Technical Services function. Provide support to manufacturing and quality control to resolve technical issues. Assure that the transfer of analytical technology from Product Development and external sources to manufacturing operations meets established and expected quality, regulatory and customer requirements.
• Direct the process for monitoring USP compendia! changes and assuring products are compliant with current compendia! standards.

Requirements

• Accomplished quality leader with relevant experience in injectable, aseptic pharmaceutical manufacturing operations.
• Bachelor's degree required
• Significant quality control laboratory, technical operations and management experience, 10+ years
• 5 years minimum of management experience
• Proven leadership ability in managing and leading multidisciplinary teams
• Proven experience in devising and leading change, results orientation, action bias
• Strong analytical problem-solving experience essential. Demonstrated ability to troubleshoot and resolve complex technical and manufacturing problems.
• Ability to effectively interact with and influence third party partners, suppliers/vendors, regulators, global partners or affiliates, industry executives and trade organizations.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

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.

Job Tags

Similar Jobs