Site Quality Head

EUROAPI is looking for a new Site Quality Head for the Vertolaye site in Auvergne (63). Our site (700 people) has the mission to manufacture more than 65 APIs (active pharmaceutical ingredients) in compliance to GMP (Good Manufacturing Practices) and to ICH Q7, representing 500 different chemical steps ranging from Chemistry to Milling, Micronization. As a worldwide company, our products are sold all over the world to more than 300 clients. We are inspected by all National Health Authorities (ANSM, US FDA, ANVISA, …) and are hosting more than 15 customer audits per year.

The Quality team is composed of around 90 people in 5 units: QA Production, QA Assurance, QA New Projects, Regulatory Affairs and Quality Control.

Responsibilities

• Lead the Quality department (approx. 90 people) consisting of Quality Assurance Production, Quality Assurance Systems, Regulatory Affairs, projects and Quality Control, providing direction to all departments and employees to deliver consistent compliance and high performance.
• Coordinate the Quality Unit group and monitor the objectives agreed with the direct managers and functional managers.
• Ensure strict compliance of the production activities of EUROAPI France Vertolaye with the Good Manufacturing Practices and the quality standards defined by the Company.
• Verify and report any existing gap situations and cooperate for the resolution of the same.
• Coordinate the Quality activities in the Vertolaye Site for the achievement of the objectives agreed with the hierarchical superior and with the functional manager in compliance with current regulations.
• As part of the site leadership team, develop and manage strategies designed to place the business in a highly competitive position, including development and maintenance of strategy for the Quality function in alignment with the corporate Quality strategy.

Additional Responsibilities

• Take final decision on acceptance for use or rejection of materials including raw materials, packaging material, intermediates, active pharmaceutical ingredients.
• Conduct verification of compliance of products with registration dossier requirements.
• Conduct verification that programs and systems are implemented to consistently identify, analyse, evaluate, control and review potential or identified risks related to quality and compliance.
• Review and approve changes that could potentially impact quality of the product and registered regulatory dossiers.Manage expertise studies to ensure state of the art compliance of APIs.
• Approve subcontractors and suppliers involved in GxP activities and maintenance of their approved status, including quality assessments, audits, and approval of quality agreements.
• Manage customer quality audits and regulatory authorities inspections.
• Manage quality documentation, including review and approval of documentation with GxP impact.
• Manage Good Manufacturing Practices training program for employees and new comers.
• Monitor Quality indicators and conduct site quality reviews.
• Promote a fully interdependent culture in which everyone takes responsibility for reducing product quality risk, preventing accidents, avoiding health risks, wellbeing promotion and reducing environmental impacts.
• Contribute to the development of CDMO activities by providing quality support to R&D and Process Development teams in introducing new products on site.
• Prepare and manage annual budgets and capital plans for the Quality department, and be responsible for budgetary control, ensuring that any deviations from the approved capital plans are addressed and that quality risks are addressed as part of this plan.

Education and Experience

• Professional qualification in Chemistry, Microbiology or Pharmacy.
• 5 to 10 years in Quality Management in API / CDMO or Pharma industry in a operational management position.
• Strong background in GxP compliance activities & ICH Q7 knowledge.
• Substantial experience of successfully working at a senior level and be able to demonstrate a broad and deep technical and managerial understanding.

Technical skills

• Expertise in Quality Management system.
• Advanced Knowledge in Regulatory and company requirements, specifically pharmaceutical drug Regulations, e.g. drug law, Good Manufacturing Practices, Pharmacopeia, ICH.
• Good Manufacturing Practices expertise.
• English is a MUST.
• Role holder is a highly independent strategic thinker and has strong compliance mindset, results-driven, can-do-attitude, solution-oriented, change-agent, customer centric mindset, resourceful, and innovative.
• Role provides a key link between the Site, the global Quality organization, the operational/sales units and the customers.
• Knowledge in Regulation on Narcotics and Psychotropics is a plus.

Soft skills

• Good leadership and influencing skills to operate in a cross-functional and international environment.
• Good communication (both written and oral) skills.
• Active listening, information gathering, synthesis and ability to synthesize information.
• Strong ability to decide, challenge and act for change.
• Cooperate transversally.
• Drive a culture of continuous improvement to improve processes and organization effectiveness.