Head of Site Quality Operations

Role Summary

Head of Site Quality Operations. Location: Swiftwater, PA.

Responsibilities

• Ensure that all site activities are conducted in compliance with applicable regulatory requirements and that valid manufacturing licenses and marketing authorizations are maintained. Ensure that the Swiftwater manufacturing operations operate in full compliance with the applicable regulations and registrations in a sustainable and consistent way for guaranteeing that manufactured products are of the appropriate quality and safety prior to the product release and throughout shelf-life.
• Ensure that applicable requirements are included in development and technical transfers for an effective and efficient industrialization, regulatory submission and timely approval. Represent the site towards the concerned health authorities as the Quality head of the site with regards to product quality, safety and cGMP compliance as well.
• Oversees the QC activities to guarantee that all products are tested and compliant with applicable standards and specifications. Manage the QC testing operations in an efficient and compliant manner to guarantee product availability for market release in a timely manner and cost-effective way.
• Lead the SQC to provide direction and guidance to sustain quality and compliance. As head of Quality Department, raise compliance and quality issues and solutions/ proposals to senior management. Develop, maintain and control departmental capital and operating expense budgets.
• Provide guidance and technical support to the company for project planning, process, systems and computer validation, aseptic processes and validation, component/ product release, trending, problem investigations, product assessment, disposition, complaint management, records retention, document distribution & audit.
• Lead the site‚Äôs quality management system to ensure continuous compliance and certification. Ensure the implementation and maintenance of robust quality systems, in line with global quality.
• Develop and oversee the implementation of site quality roadmap in line with site CBN and global quality objectives and strategy.
• Support and provide guidance to Protein Sciences, NY site Quality team as needed.
• As the head of Quality, manage budget, supervise staff in accordance with Company commitment and appropriate policies and procedures. Lead and manage the quality team including hiring, training, coaching, professional development, and performance evaluation.
• As a member of the SLT (Site Leadership Team) ensure appropriate leadership and management presence. Through the functional reporting line to Corporate Quality, ensure alignment of site programs and objectives with the Corporate (Sanofi) and Global (Sanofi) functions.
• Promote a culture of quality throughout the site organization. Foster continuous improvement and economical performance, innovation, and the implementation of new technologies, tools, and methods.

Qualifications

• Bachelor's Degree in Science required (Master's/Doctorate in Science preferred) with a minimum of 15 years experience in pharmaceutical or related industry with a concentration in Quality Operations. Background in manufacturing and development, Quality Assurance, Quality Control, and Regulatory Affairs.
• Competencies (LEAD model) ‚Äì key competencies the job holder will be evaluated on (HOW in 9box): This position is measured on all 8 competencies, Act for Change, Cooperate Transversally, Strive for Results, Thinking Strategically, Commit to Customers, Develop People, Make Decisions, Lead Teams.
• Deep and practical expertise with cGMP requirements including WHO, ICH, US FDA, Canadian BGTD, Australian TGA, EU GMP, Japanese‚Ķ ; but are not limited to the named Health Authorities and organizations.
• Strong technical expertise in Biotech manufacturing.
• Must be able to work strategically in a fast paced environment and make balanced decisions related to quality.
• Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization.
• Experience interacting with regulatory agencies and health authority inspections is required.
• Excellent organizational, interpersonal and leadership/teamwork abilities are required.
• A strong customer focus and ability to prioritize and adapt to business and manufacturing needs are required.
• Diverse business, quality, and industrial manufacturing knowledge base.

Skills

• Quality systems leadership
• Regulatory compliance and cGMP
• Quality Assurance and Quality Control management
• Regulatory affairs interface with health authorities
• Process validation, computer validation, and aseptic processes
• Budgeting and people management
• Strategic planning and quality roadmap development
• Communication across multi-site organizations

Education

• Bachelor's Degree in Science required; Master‚Äôs/Doctorate preferred.

Additional Requirements

• Experience with regulatory inspections and health authority interactions.
• Ability to lead large teams and manage global quality programs.