Quality Assurance Manager

Quality Assurance Manager - Biologics

INTERESTED CANDIDATES PLEASE REACH OUT TO CARRIE AT CSTUDEBA @ACTALENTSERVICES.COM OR TEXT 937. 903. 3402 TO SET UP A PHONE INTERVIEW!

The Biologics Quality Assurance Manager will provide leadership in formulating regulatory policy, including resource management and the development, implementation, and maintenance of a Quality Management Program for Investigational New Drugs (IND) , Biologics, and Good Tissue Practice programs. The role involves leading quality input in process development, IND 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 under the direction of the Research Compliance & Integrity departments.

Responsibilities

• Establish and maintain an appropriate quality system to ensure compliance with regulatory requirements.
• Register, distribute, and maintain controlled documents including Quality Management Plan, Batch Record Documents, SOPs, Master Validation Plans, Validation Protocols, and Quality Assurance Manual.
• Represent the Biologics Manufacturing Facility during client and regulatory inspections.
• Represent the research institute during regulatory inspections.
• Ensure that quality system requirements are met according to FDA guidelines and industry standards for the manufacture of biologics and Good Tissue Practices.
• Collaborate with Scientists, Biologics, and Facility Management Teams for deviation investigations, process change controls, and 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.
• Oversee product development including raw material technical specifications and supplier selection.
• Approve and release products (investigational drug/device) for use in clinical trials in accordance with 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 the1st 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.

This is a Contract to Hire position based out of Columbus, OH.

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:
• 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)

This is a fully onsite position in Columbus,OH.

This position is anticipated to close on Apr 21, 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, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with 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 actalentservices.com.

Salary : $43 - $55