Director Quality Control

American Regent; Columbus (OH); On-site; USD 140,000 - 190,000; Full time

Job summary

American Regent in Columbus, Ohio seeks a Director of Quality Control to lead all laboratory activities supporting manufacturing and R&D, including analytical, microbiology and environmental monitoring across the New Albany and Hilliard facilities.

This role requires strategic oversight, hands-on management of CAPAs and deviations, and collaboration with Production, Regulatory Affairs and QA Compliance to implement new testing technologies and ensure strict cGMP and safety standards.

Qualifications

• Bachelors in Life Sciences at minimum; advanced degree preferred.
• Minimum 12 years of experience in pharmaceutical manufacturing.
• Minimum 8 years of management experience.
• Experience with TrackWise for Deviations, CAPAs and CR processes.
• Experience with environmental monitoring systems (Lighthouse) and method development in microbiology/analytical.

Responsibilities

• Lead day-to-day laboratory activities in support of manufacturing and R&D across multiple Ohio sites.
• Oversee analytical, microbiology, and environmental monitoring testing.
• Write, review, and approve validation and qualification SOPs; drive CAPA processes.
• Ensure cGMP/GLP compliance and support regulatory filings and audits.
• Hire, train, and manage laboratory personnel; provide coaching and mentoring.
• Collaborate with Production, Regulatory Affairs, Engineering, and QA Compliance on technology and process improvements.

Skills

TrackWise

Environmental Monitoring

Method Development

cGMP Compliance

MS Office

Leadership

Regulatory Compliance

Education

Bachelor's in Life Sciences

Advanced Degree preferred

Tools

Lighthouse Environmental Monitoring

Job description

Nature and ScopeThis 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 ResponsibilitiesNothing 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 requiredSupervise 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 QualificationsTo 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 RequirementsEmployee 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.pdfKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdfAlert: We’re aware of individuals impersonating our staff to target job seekers. Please note:· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.· Our recruiting process includes multiple in person and/or video interviews and assessments.· If you are unsure about the legitimacy of a message, contact John Rossini at [e-mail] before responding.· We never request payment, bank information, or personal financial details during our offer process.Your security is important to us, and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].