What are the responsibilities and job description for the DIRECTOR, LABORATORY OPERATIONS position at Fresenius Kabi USA, LLC?
PRINCIPAL ACTIVITES PERFORMED BY THE INCUMBENT
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.
MANAGEMENT SCOPE
Act as Quality Control Management lead for FDA site inspectors
Manages, mentors and coaches 4 or more employees. Has hiring, firing and performance decision power
Manages, mentors and coaches less than 3 employees. Has hiring, firing and performance decision power
Manages, mentors and coaches other employees. Does NOT have hiring, firing and performance decision power
Does NOT manage other employees. Does NOT have hiring, firing and performance decision power
REQUIREMENTS
Accomplished quality leader with relevant experience in injectable, aseptic pharmaceutical manufacturing operations.
- Significant quality control laboratory, technical operations and management experience, 10 years
- 5 years 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.
Advanced degree in chemistry, microbiology or engineering fields preferred.
Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness 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.
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, disabilities, or protected veteran status.
