Job Description
Quality Assurance Manager INTERESTED CANDIDATES PLEASE REACH OUT TO CARRIE AT DASILVA @ACTALENTSERVICES.COM OR TEXT 419. 575. 8973 TO SET UP A PHONE INTERVIEW! The Quality Assurance Manager will provide leadership in formulating regulatory policy, resource management and the development, implementation, and maintenance of a Quality Management Program for Investigational New Drugs (IND) , Biologics, and Tissue programs. The role involves leading quality input in process development, manufacturing, and quality control of biologics manufacturing program. The individual will manage the implementation of quality management systems to ensure product safety and regulatory compliance. Establish and maintain appropriate quality system to ensure compliance with regulatory requirements. Register, distribute and maintain controlled documents including but not limited to Quality Management Plan, Batch Record Documents, Standard Operating Procedures (SOPs), Master Validation Plans, Validation Protocols and Quality Assurance Manual. Represent the Biologics Manufacturing Facility during client and regulatory inspections. Represent the Research Institute (RI) during regulatory inspections. Ensure that requirements for quality systems are met according to FDA guidelines and industry standards for the manufacture of biologics and an overall program for Good Tissue Practices. Work closely with the Scientists, Biologics and Facility Management Teams for deviation investigations, process change controls and implementation of process improvement changes. Perform internal and external audits to ensure compliance with regulatory and internal guidelines., Provide cGMP training to staff on a continuing basis. Provide oversight to product development including raw material technical specifications and supplier selection. Approve and release product (investigational drug/device) for use in clinical trials and as appropriate to Good Tissue Practices. Assign and delegate responsibilities to Biologics QA Auditors. Develop and collaborate with Biologics Manufacturing Leadership on continuous improvement and CAPA projects. Essential Skills Master's degree in life sciences discipline with a minimum of 5+ years of quality or regulatory experience, or BA with 8+ years. Prior leadership experience. Experience in cell & gene therapy, pharma, cosmetics, or food and beverage industries with FDA and GMP experience. Knowledge in Pharmaceutical Good Manufacturing Practices (GMP) or GLP. Experience with cGMP practices relative to biological products and cell cultures. Strong technical documentation and auditing skills. Proficiency in Microsoft Office Suite, SharePoint, and Quality Management Systems. Experience in conducting audits and technical writing. Ability to guide and train QA staff. Additional Skills & Qualifications Strong interpersonal, organizational, and leadership skills. Experience in SOP writing is preferred. Work Environment The work environment is highly team-oriented and diverse, with a growing team. Work is conducted on-site 100% during the 1st shift from Monday to Friday, 8:00 AM to 4:30 PM, with occasional overtime. The role requires frequent gowning up due to proximity to the clean room. Job Type & Location This is a Contract to Hire position based out of Columbus, OH. Pay And Benefits The pay range for this position is $42.78 - $55.29/hr. Requirements Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Columbus,OH. Application Deadline This position is anticipated to close on May 22, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who d