Job Description

Job Description

Job Description

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.

We are currently seeking a highly skilled Change Control Lead with experience in optimizing change control processes for a project with one of our clients. Project is estimated to be 3 months in length. This role must be performed onsite. Our client is based in the greater Columbus, Ohio area. Local candidates preferred.

Title: Change Control Lead

Position Summary

The Change Control Lead is responsible for managing and optimizing the change control process within a Contract Development and Manufacturing Organization (CDMO) . This role ensures that all changes to GMP manufacturing processes, facilities, equipment, testing and documentation comply with FDA, EMA, and ICH guidelines, as well as advanced therapy medicinal product (ATMP) requirements. The position focuses on maintaining compliance while driving efficiency and supporting business objectives in a fast-paced, highly regulated environment.

Key Responsibilities

• Change Control Management
• Lead and oversee the change control process for GMP-related systems, viral vector production processes, and controlled documents.
• Review and approve change requests, ensuring compliance with SOPs, regulatory requirements, and applicable regulatory guidelines.
• Facilitate cross-functional impact assessments (QA, Manufacturing, Process Development, QC, Validation, Regulatory Affairs) and risk evaluations for proposed changes.
• Process Optimization
• Analyze current change control workflows and identify opportunities to streamline processes without compromising compliance.
• Implement best practices and automation tools to improve efficiency and reduce cycle times, supporting rapid development and manufacturing timelines.
• Collaborate with stakeholders to align change control improvements with business goals and client expectations.
• Quality Assurance Oversight
• Ensure changes meet cGMP standards and regulatory expectations (FDA 21 CFR Parts 210/211, EU GMP, ICH Q10, ATMP guidelines).
• Partner with QA and Validation teams to ensure proper qualification and validation activities for viral vector processes and equipment.
• Monitor change control KPIs and provide reports to senior management and clients as needed.
• Documentation & Compliance
• Maintain accurate records in the electronic Quality Management System (eQMS).
• Support internal and external audits, including FDA, EMA, and client inspections, by providing change control documentation and any corresponding responses.
• Continuous Improvement & Training
• Drive initiatives to enhance change control effectiveness and compliance in a CDMO setting.
• Train staff on change control procedures, optimization strategies, and regulatory expectations for gene and viral vector manufacturing.

Qualifications

• Education: Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
• Experience:
• Minimum 5 years in Quality Assurance within a Biologics GMP-regulated pharmaceutical or biotech environment.
• At least 2 years of experience managing and optimizing change control processes in a CDMO or ATMP setting.
• Skills:
• Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and ATMP regulatory requirements.
• Proven ability to implement change control efficiency measures in a fast-paced environment.
• Excellent organizational, analytical, and communication skills.
• Proficiency in eQMS platforms and Microsoft Office Suite.

Preferred Qualifications

• Experience supporting FDA, EMA, and client audits in a CDMO environment.
• Familiarity with viral vector manufacturing processes and associated risk management tools (FMEA, risk assessments).

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.

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