Quality Systems Specialist

Job Title: Quality Systems Specialist – Auditing and Vendor Management

Job Description

The Quality Systems Specialist plays a key role in supporting cGMP quality system activities within a biopharmaceutical manufacturing environment. This position focuses on executing and maintaining processes within the MasterControl electronic Quality Management System (eQMS), building and managing a robust supplier and vendor quality program, and ensuring compliance with internal procedures and global regulatory requirements. The specialist reviews validation and qualification documentation, oversees GMP training programs, and supports deviations, investigations, CAPAs, change controls, and Annual Product Review (APR) preparation. This role requires up to 50% domestic and international travel to qualify and audit suppliers and partners.

Responsibilities

• Execute and maintain cGMP quality system activities using the MasterControl electronic Quality Management System (eQMS).
• Build, implement, and manage a comprehensive supplier and vendor quality program.
• Plan, conduct, and document qualification and auditing of suppliers, including up to 50% domestic and international travel.
• Support and administer GMP training programs, ensuring accurate and current training records.
• Review and approve validation and qualification documentation to ensure compliance with cGMP and internal procedures.
• Participate in and support the management of deviations, investigations, and CAPAs, ensuring timely closure and effective corrective and preventive actions.
• Manage and oversee change controls, including coordination of change control governance and documentation.
• Support and coordinate internal and external audits, including preparation, facilitation, and follow-up activities.
• Maintain and oversee document control and batch record review activities within the quality management system.
• Ensure compliance with FDA and other global regulatory requirements, as well as internal quality policies and procedures.
• Support the preparation and execution of Annual Product Reviews (APRs).
• Collaborate cross-functionally with manufacturing, quality control, supply chain, and other departments to support continuous improvement of quality systems.
• Contribute to the development, implementation, and improvement of quality assurance processes, procedures, and work instructions.
• Monitor quality system metrics and provide input on trends, risks, and opportunities for improvement.

Essential Skills

• Bachelor’s degree or higher in a scientific discipline.
• 5+ years of quality experience in the biopharmaceutical or pharmaceutical industry, preferably with a focus on vendor management and auditing.
• Strong hands-on experience with quality assurance in a cGMP-regulated environment.
• Proficiency in quality auditing and internal audit processes.
• Experience managing vendor and supplier qualification and oversight programs.
• Demonstrated knowledge of CAPA processes, including investigation, root cause analysis, and implementation of corrective and preventive actions.
• Solid understanding of FDA regulations and global regulatory expectations for biopharmaceutical manufacturing.
• Experience with quality management systems and document control, including batch record review.
• Ability and willingness to travel up to 50% domestically and internationally.

Additional Skills & Qualifications

• Experience working with MasterControl or similar electronic Quality Management Systems (eQMS).
• Experience in managing and improving quality systems in a biopharmaceutical manufacturing environment.
• Familiarity with change control governance and oversight.
• Experience supporting Annual Product Review (APR) activities.
• Demonstrated ability to support and deliver GMP training programs.
• Proven ability to support continuous improvement initiatives within quality systems.
• Strong organizational skills and ability to manage multiple priorities, audits, and projects simultaneously.

Work Environment

This is a first-shift, full-time role, working Monday through Friday with a flexible start time between 7:00 a.m. and 9:00 a.m., for an eight-hour workday. The position is based in a biopharmaceutical manufacturing environment and operates within a collaborative quality organization that includes Quality Management System Specialists and Document Control Technicians. The team works closely together on-site to support production and quality activities. The role involves significant domestic and international travel, up to 50% of the time, to conduct supplier and vendor audits and qualifications. Work is primarily office-based within a GMP manufacturing campus, using electronic quality systems and standard office and laboratory documentation tools

This is a Permanent position based out of Madison, WI.

The pay range for this position is $62000.00 - $90000.00/yr.

Competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k

This is a fully onsite position in Madison,WI.

This position is anticipated to close on Apr 27, 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.