Tunnell Consulting, Inc. · 18 hours ago
Change Control Lead
Columbus, OH
Full-time
Onsite
Senior Level
5+ years expTunnell Consulting is an employee-owned, life sciences management consulting firm. They are seeking a highly skilled Change Control Lead responsible for managing and optimizing the change control process within a Contract Development and Manufacturing Organization (CDMO), ensuring compliance with regulatory guidelines while driving efficiency.
BiotechnologyConsultingInformation Technology
Responsibilities
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
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
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
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
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
Qualification
Required
Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field
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
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
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)
Company
Tunnell Consulting, Inc.
With a strong focus on the life sciences industry, Tunnell Consulting designs and implements sustainable solutions that improve the operating performance of each unique client we serve.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Larry Frattura
Chief Financial Officer
Ann McNulty
Senior Talent Acquisition Partner
Recent News
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