Head of Bio QA and Alliance Quality

Job Description

About This Role

The Head of Bio QA and Alliance Quality is a key member of the Site Leadership Team and​ has the overall responsibility for Global Quality Assurance operations at the RTP Bio site – including the Large Scale Manufacturing facility, Small Scale Manufacturing Facility, Flexible Volume Manufacturing, and Cell Banking operations.  This position has a heavily strategic component, responsible for the relationships with senior management of key partner and joint venture organizations pertaining to site operations. This position is also responsible for oversight of the Quality strategy for the assigned Biogen contract and/or internal program, including partner audit management and audit responses as well as the management of regulatory inspections related to partner programs or products.

This function has the responsibility to ensure the requirement of Global Quality System regulations are effectively established and maintained to provide PO&T with scalable Quality activities within the following business areas:

• Disposition, release, and distribution of commercial and clinical drug substance
• Oversite of the engineering, facilities, maintenance, validation, QC, and manufacturing operations at the site
• Quality Engineering support of site expansions, upgrades, and operations
• Overall responsibility for site Change control, investigations, deviations, and site-related GxP documentation
• Inspection readiness for all global regulatory markets (US, EU, Japan, BIR, MENA, etc.)  including inspections from partners and joint venture organizations.
• Oversees key interfaces and strategy for Biogen contracts and/or internal programs and guarantee the product release/distribution as current partnership agreements.

What You'll Do

Quality oversight of Biogen manufacturing operations at the RTP BioManufacturing Site:

• Develop and maintain strong and efficient relationships with internal partners (Manufacturing, Regulatory Affairs, Human Resources, Legal, Sourcing, and Finance) to ensure Global Quality goals and objectives are met. Lead, participate in, and provide direction to cross-functional teams related to product investigations, regulatory audits/inquiries, implementation of new/revised GxP guidelines, and PO&T strategic improvement initiatives
• Influence and Negotiate Quality Agreements with corporate partners.
• Participate in BIIB Health Authority across multiple markets and manage RtQs associated with regulatory questions.
• Develop and maintain strong and efficient relationships with external partners to ensure adherence to Biogen standards, cGMP's and regulatory agency guidelines
• Ensure performance is tracked and reported during Biogen management reviews. Develop and ensure execution and effectiveness verification of improvement action plans.
• Lead strategic initiatives to re-engineer business processes within Site Quality and within the PO&T organization
• Make decisions regarding product disposition including release to market, regulatory reporting, and product disposition for all Biogen commercial and clinical products manufactured at the site
• Influence the development and execution of the Biogen External Supply Network Strategy and Vision
• Develop and implement an onboarding quality strategy for partner / acquired clinical assets

Ensure that the facilities, procedures, equipment, personnel, and process are continually evaluated and improved to ensure compliance.  Oversee the development, implementation, and maintenance of site Quality Systems that conform to Biogen Global Standards and Practices and cGMP:

• Manage the QMS team for oversight of GxP activities with a focus on GMP manufacturing for commercial and clinical products. Ensure manufacture and distribution of Biogen products is performed in a safe, compliant manner, meeting the requirements defined by Biogen regulatory submissions, cGxP requirements, and Biogen Quality Agreements.
• Ensure that the Global Quality QMS is applied at all sites in accordance with the Global QMS
• Ensure that superuser support is maintained for critical business systems, including Oracle, Trackwise, PLM, and BIU
• Support site and global management reviews as well as partner management reviews

Lead and develop global teams:

• Recruit, retain, and develop strong QA talent responsible for the management of quality operations to ensure the compliance of commercial and clinical products. 
• Direct the Quality teams, including personal performance and development, in support of Corporate and Dept goals. Ensure team members are empowered, motivated, and have adequate development plans.
• Manage the utilization of Quality res