Quality Assurance Manager

Quality Assurance Manager INTERESTED CANDIDATES PLEASE REACH OUT TO CARRIE AT CSTUDEBA @ OR TEXT 937. 903. 3402 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. 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 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 Apr 23, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at .

Created: 2026-04-13