Director Quality Control

American Regent • Columbus, OH

1d • Hybrid

About The Position

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.

Requirements

• Bachelors in Life Sciences required at Minimum.
• Minimum of 12 years of experience in pharmaceutical manufacturing industry required.
• Minimum 8 years management experience required.
• Experience with Trackwise for Deviations, CAPAs and CR process.
• Experience with Lighthouse, or equivalent, environmental monitoring systems, including implementation and operation.
• 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.

Nice To Haves

• Advanced Degree in preferred.
• Exceptions may be considered for outstanding candidates with proven expertise.
• Experience with method development, in microbiology and/or analytical methods is desired.

Responsibilities

• 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.
• Perform any other tasks/duties as assigned by management.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director