Director Quality Control

Nature and Scope

This Director Quality Control is a member of the Quality Assurance team and is responsible for leading all laboratory activities in support of manufacturing and R&D. This position is responsible for leading the analytical microbiology and environmental monitoring activities for a multi-site sterile manufacturing operation.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

• Manage the day-to-day activities in the laboratories in support of both operations and R&D functions as well as Environmental Monitoring Technicians in manufacturing at New Albany and Hilliard manufacturing Facilities.
• Manage testing programs including analytical sterility bioburden and microbiological tests as necessary.
• Manage identify and introduce new testing methodologies for applicable testing procedures.
• Manage and perform trend analysis for all operations.
• Provide support in front of regulatory agencies eg: FDA/ CDER-CBER customer audits corporate auditors Health Canada EMA internal audits and as required
• Supervise the certification of laboratory technicians on various test procedures per USP FDA PDA and EU guidelines.
• Hire train and manage performance of existing and future laboratory personnel and technicians.
• Write review and approve validation and qualification SOPs.
• Provide expertise in EMPQ qualifications new sterile filler qualifications new water systems qualifications new laboratory space qualifications and disinfectant study qualifications.
• Ensure laboratories maintain compliance with cGMPs/GLPs support validation regulatory filing R&D Metrology Engineering QA manufacturing and formulation operations.
• Identify evaluate purchase and qualify laboratory equipment.
• Direct perform and resolve out-of-specification investigations deviations and implement CAPAs.
• Have knowledge of and support the Sterility Assurance Utilities process Cleaning & Disinfection process and Traffic & Gowning process of sterile manufacturing.
• Train coach mentor and supervise direct reports.
• Oversee trouble shoot and investigate outsourced testing for products and components.
• Partner with Production Regulatory Affairs Engineering and QA Compliance to strategize and organize implementation of new technology processes and products.
• Identify and facilitate process improvements to increase efficiencies in systems operations and personnel.

• Ensure all work is performed and documented in accordance with existing Company policies and procedures as well as cGMP and health and safety requirements.
• Position has responsibilities at multiple locations in central Ohio and provide input as requested with ARI Shirley NY on microbiology issues.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

• Bachelors in Life Sciences required at Minimum. Advanced Degree in preferred.
• Minimum of 12 years of experience in pharmaceutical manufacturing industry required.
• Minimum 8 years management experience required. Exceptions may be considered for outstanding candidates with proven expertise.
• Experience with Trackwise for Deviations CAPAs and CR process.
• Experience with Lighthouse or equivalent environmental monitoring systems including implementation and operation.
• Experience with method development in microbiology and/or analytical methods is desired.
• Demonstrated expertise managing cGMP laboratory.
• Strong knowledge of contamination control disinfection microbiology sterility assurance aseptic processing cGMPs and regulatory requirements.
• Strong knowledge of MS-Office software and PC Skills required.
• Excellent leadership communication organizational interpersonal and communication skills (oral and written).
• Proven record of people and program management skills.
• Ability to work independently and deliver timely results.
• Ability to work off hours and weekends as needed.

Physical Environment and Requirements

• Employee must be able to occasionally lift and/or move up to 25 pounds.
• Physically able to wear laboratory protective gowning and equipment including but not limited to gowning goggles face shields respirators and protective and Respirators are essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.

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