Head of QA/QC, Gene Therapy Manufacturing

Job Description

Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Head of QA/QC for Gene Therapy Manufacturing has the overall responsibility for Global QA and QC operations at the Research Triangle Park, NC site. This function has the responsibility to ensure the requirements of all Quality System Regulations are effectively established and maintained to provide scalable QA/QC activities within all business areas. This role is responsible for the local implementation of global Biogen Quality systems through commissioning, validation, application of manufacturing license, regulatory approval and into GMP operations.

• Ensure that the site is GMP ready as per project schedule. This will include, but is not limited to batch release, maintaining Site Master File, Quality point of contact for technology transfer, site management review, host of audits and inspections, and being an effective liaison to corporate quality functions as well as external partners.
• Ensure that the operating paradigm based on highly integrated business execution systems are implemented compliantly while considering needs of other DS manufacturing sites
• Ensure concurrent compliant routine batch operations and Capital project execution, leading the transition to fully operational DS site
• Design and manage the Gene Therapy QA and QC organization of leaders and subject matter experts who themselves are responsible for specific functions according to job descriptions
• Lead site QA/QC within the global quality organization to ensure local implementation of the global QMS and lead quality system changes as required by the operation paradigm and continuous improvements
• QA oversight of QC, manufacturing, and engineering activities across the site
• Quality Engineering support of ongoing site expansions
• QA oversight of deviations, change controls and all GMP documentation
• Responsible for inspection readiness and execution
• Accountable for batch disposition and operational QA/QC decisions according to Global QMS and appropriate regulations
• Design, review and maintain elements of the integrated schedule and quality plan for the RTP plant to ensure readiness as per project timeline
• Responsible for hosting internal and external audits and regulatory inspections to successful outcomes for the Site
• Initiate, sponsor, and support continuous improvement and strategic projects across the site
• Responsible for relationships with senior management of key partners and/or joint venture organizations with respect to Quality matters

You are a strategic leader that influences business outcomes with high quality manufacturing decisions. You are dedicated to contributing to the generation of pioneering gene therapies.

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Qualifications

• University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines

• Typically requires 12-15 years'experience in pharmaceutical or biotech manufacturing environment
• Prior experience with facility construction and operation
• Proficiency with Quality System and business processes associated with automation and integration of testing and production systems
• Strong communication and stakeholder management skills
• Strong GxP knowledge

• Prior experience with site operations and startups
• Prior experience with Gene Therapy operations

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.