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 management’s 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 gloves. PPE 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.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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