Responsable département qualité

With approximately €1 billion in sales in 2022, EUROAPI ranks #1 in small molecules APIs, and our strong innovation and R&D capabilities allow us to accelerate our development in more complex molecule segments through CDMO activities.

At approximately 200 APIs, EUROAPI offers one of the largest portfolios in the industry, addressing a wide variety of patients and providing coverage for more than 80 countries.

We provide expertise in Quality, Regulatory and Supply and have dedicated commercial teams for our clients around the globe.

We are looking for our new Site Quality Head for the Vertolaye site.

The Site Quality Head is responsible for :

Leading the Quality department, consisting of Quality Assurance Production, Quality Assurance Systems, Regulatory Affairs, and Quality Control, providing direction to all departments and to all employees to deliver consistent compliance and high performance.

Coordinating the Quality Unit group and monitoring the objectives agreed with the direct managers and with the functional managers.

Ensuring strict compliance of the production activities of EUROAPI France Vertolaye with :

• the Good Manufacturing Practices and
• the quality standards defined by the Company,

Verifying and reporting any existing gap situations and cooperating for the resolution of the same.

Coordinating 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, the future Site Quality Head develops and manages 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.

And more especially but not limited :

• takes final decision on acceptance for use or rejection of materials including raw materials, packaging material, intermediates, active pharmaceutical ingredients;
• Conducts verification of compliance of products with registration dossier requirements;
• Conducts verification that programs and systems are implemented to consistently identify, analyse, evaluate, control and review potential or identified risks related to quality and compliance;
• Reviews and approves changes that could potentially impact quality of the product and registered regulatory dossiers;
• Manages expertise studies to ensure state of the art compliance of APIs;
• Approves subcontractors and suppliers involved in GxP activities and maintenance of their approved status, including quality assessments, audits, and approval of quality agreements;
• Manages customer quality audits and regulatory authorities inspections;
• Manages quality documentation, including review and approval of documentation with GxP impact;
• Manages of Good Manufacturing Practices training program for employees and new comers;
• Monitors Quality indicators and conducting site quality reviews;
• Promotes 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;
• Contributes to the development of CDMO activities by providing quality support to R&D and Process Development teams in introducing new products on site;
• Prepares and manages annual budgets and capital plans for the Quality department, and is 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
• We expect you to have professional qualification in Chemistry, Microbiology, Pharmacy, Engineering or equivalent
• At least 5 years in Quality Management in API or Pharma industry with a good mix of leadership, technical and operational experience is a plus;
• Strong background in GxP compliance activities;
• International exposure;
• Professionally qualified and has substantial experience of successfully working at a senior level and be able to demonstrate a broad and deep technical and managerial understanding;
• Successful management experience and an advanced grasp of management techniques;
• 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;
• The 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;
• The 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.
• 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;
• Act for change;
• Cooperate transversally;
• Drive a culture of continuous improvement to improve processes and organization effectiveness.
Il y a 26 jours