Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
Tunnell Consulting is an employee-owned, life sciences management consulting firm. We are known for solving complex problems in life science, and we support the mission and objectives of biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. Tunnell is headquartered in the Philadelphia area with offices in Washington DC, and Boston.
We are seeking support of a Quality Assurance SME for an engagement with a CDMO in Denmark. This is a full-time contract role. Work will need to be completed onsite. Project is estimated at 6 months (possible extension).
Role Title: Quality Assurance SME

POSITION SUMMARY:

The QA SME will ensure the accuracy, completeness, and compliance of manufacturing documentation for a client-sponsored program in both upstream and downstream GMP operations. The QA SME will work closely with MS&T colleagues serving as a key quality liaison between internal manufacturing and external clients. This role is responsible for paper-based batch record review, managing deviations, and ensuring timely, high-quality deliverables to support product release and regulatory compliance.

QUALIFICATIONS:

• BS or MS degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline.
• 5+ years of experience in biologics manufacturing, with direct involvement in mammalian cell culture - upstream and/or downstream operations.
• Proven experience in a CDMO or multi-client manufacturing environment.
• Demonstrated expertise in PPQ execution and associated regulatory expectations.
• Strong knowledge of GMP regulations, quality systems, and deviation/investigation lifecycle.
• Exceptional written and verbal communication skills; experience presenting to clients and cross-functional stakeholders.
• Expertise in paper-based batch record review and deviation investigation.
• Experience interfacing directly with clients on quality and compliance matters.
• Exceptional attention to detail, organizational skills, and ability to manage multiple projects in a fast-paced, client-driven environment.
  Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
  Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols

• Perform detailed review of paper-based batch records for upstream and downstream manufacturing campaigns to ensure GMP compliance and data integrity.
• Identify, document, and evaluate deviations, collaborating with Manufacturing, MS&T, and client QA teams to determine root cause, assess product impact, and ensure timely closure.
• QA SME for batch record review and deviation investigation processes in a CDMO setting, ensuring client-specific requirements are met.
• Ensure all reviewed records and deviation reports meet GMP, regulatory, and client-specific quality standards.
• Support client audits and regulatory inspections by providing reviewed records, deviation reports, and subject matter expertise.
• Partner with MS&T and operations to ensure process knowledge and client-specific technical requirements are accurately reflected in documentation.