Vice President, Quality Control

Role Summary

Vice President, Quality Control overseeing the Quality Control organization with full accountability for staff and operations, including precommercial program development and commercial program lifecycle management. Requires leadership to guide teams, apply cGMPs and multinational regulations, and ensure regulatory-ready, compliant operations with expertise in analytical methods for biologics across drug substance, product, and finished product, including combination products with a device component.

Responsibilities

• Oversee the operations of all Quality Control activities for internal and external testing
• Provide input and guidance to strategic partners
• Represent the QC organization in interactions with Regulatory Affairs, Clinical, Project Management, Manufacturing, Finance, etc.
• Establish, oversee, and manage QC documentation systems including change control, SOPs, protocols/reports, training records, and job descriptions
• Lead the implementation of a QC System ensuring all QC testing complies with CMC requirements and internal SOPs
• Assist in developing and managing a comprehensive budget for Quality Control activities
• Provide mentorship to direct reports and maintain clear communication on performance
• Alert executive management of product quality issues for escalation to PQRB and Management Reviews
• Serve as a Senior Management representative on Quality Management Reviews and address risks related to QMS and product performance
• Travel as required domestically and internationally to ensure compliance with Quality Management Systems

Qualifications

• BS degree in relevant scientific discipline or technical field; advanced degree is preferred
• Minimum of 15 years in a Quality organization within biotechnology, including at least 10 years managing QC
• Ability to function effectively on project teams with strong leadership
• Experience with phase-appropriate approaches and extensive GMP quality systems and regulatory knowledge
• Understanding of commercialization of protein-based therapeutics in US and preferably Europe, Japan, and non-ICH geographies
• Excellent oral and written communication, auditing skills, and ability to work independently in a matrixed environment
• Hands-on, proactive, urgent, and innovative, with ability to drive execution in a matrixed, program-based setting
• Strong ability to present Quality programs to FDA and other regulatory authorities
• Persuasive with clear direction in a matrixed organization
• Strong leadership to establish and lead a high-performance Quality group
• Understanding of meeting corporate and program objectives, with high ethics
• Ability to travel up to 25% domestically and internationally
• Strong report and presentation writing and communication skills

Education

• BS degree in a relevant scientific discipline or technical field; advanced degree preferred