Head of Site Quality Operations

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Head of Site Quality Operations based in Swiftwater, PA. Leads quality and regulatory compliance for the Swiftwater site, providing quality leadership across the organization and developing and maintaining quality policies in line with global quality standards. This role is a key leader in Sanofi Global Quality and Strategy and reports to the VP, M&S Vaccines, US. Responsible for ensuring product quality and safety, cGMP compliance, and continuous improvement across site operations.

• Ensure that all site activities are conducted in compliance with applicable regulatory requirements and that valid manufacturing licenses and marketing authorizations are maintained. Ensure Swiftwater manufacturing operations operate in full compliance with applicable regulations and registrations to guarantee that manufactured products are of appropriate quality and safety prior to release and throughout shelf-life.
• Ensure that development and technical transfers include requirements for effective industrialization, regulatory submission and timely approval. Represent the site to health authorities as the Quality head with regards to product quality, safety and cGMP compliance.
• Oversee the QC activities to guarantee that all products are tested and compliant with standards and specifications. Manage QC testing operations to ensure product availability for market release in a timely and cost-effective way.
• Lead the Site Quality Committee (SQC) to provide direction and guidance to sustain quality and compliance. As head of the Quality Department, raise compliance issues and solutions to senior management; develop, maintain and control departmental budgets.
• Provide guidance and technical support for project planning, process and computer validation, aseptic processes and validation, component/product release, trending, investigations, disposition, records retention, document distribution and audit.
• Lead the site’s quality management system to ensure continuous compliance and certification; implement and maintain robust quality systems in line with global quality.
• Develop and oversee the site quality roadmap in line with site quality objectives and global quality strategy.
• Support and provide guidance to the Protein Sciences, NY site Quality team as needed.
• As head of Quality, manage budget and supervise staff; lead and manage the quality team including hiring, training, coaching, professional development, and performance evaluation.
• As a member of the Site Leadership Team (SLT), ensure leadership presence and alignment of site programs with Corporate and Global functions.
• Promote a culture of quality across the site, foster continuous improvement, innovation, and the adoption of new technologies, tools, and methods.
• Scope & Dimensions:
  The function covers the entire scope of cGMP activities within Swiftwater Manufacturing & Supply; the Site Quality Organization is approximately 300–350 headcounts; key indicators include quality metrics and regulatory inspections; the role has defined autonomy to release or reject materials, authorize or stop manufacturing activity, define mandatory cGMP requirements, review/approve quality documents and reports, and drive cGMP/RA compliance.

• Required:
  
  Bachelor's Degree in Science (Master's/Doctorate preferred) with a minimum of 15 years' experience in pharmaceutical or related industry focusing on Quality Operations; background in manufacturing and development, Quality Assurance, Quality Control, and Regulatory Affairs.
• Required:
  
  Competencies (LEAD model) including Act for Change, Cooperate Transversally, Strive for Results, Thinking Strategically, Commit to Customers, Develop People, Make Decisions, Lead Teams.
• Preferred:
  Overall strategic direction and guidance of the company’s quality and compliance policies and systems; experience with supply chain performance, testing, validation, computer systems, quality systems, training, product assessment, and continuous improvement; involvement in development-to-commercialization activities and key Sanofi policies; interaction with corporate committees and regulatory bodies.

• Deep and practical expertise with cGMP requirements (WHO, ICH, US FDA, Canadian BGTD, Australian TGA, EU GMP, Japanese authorities, and others).
• Strong technical expertise in biotech manufacturing.
• Ability to work strategically in a fast-paced environment and make balanced quality decisions.
• Effective verbal and written communication across multiple levels of the organization.
• Experience interacting with regulatory agencies and health authority inspections.
• Excellent organizational, interpersonal, and leadership abilities.
• Strong customer focus with the ability to prioritize and adapt to business and manufacturing needs.
• Diverse knowledge base across quality and industrial manufacturing.