Site Quality Head

EUROAPI; Vertolaye; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A global pharmaceutical company in Vertolaye is seeking a Site Quality Head to lead the Quality department and ensure compliance with Good Manufacturing Practices. The ideal candidate will have a professional qualification in Chemistry, Microbiology, or Pharmacy, along with significant experience in Quality Management within the pharma industry. Key responsibilities include overseeing quality audits and maintaining regulatory compliance. This position offers the opportunity to influence quality strategies while working in a collaborative environment.

Qualifications

• 5 to 10 years in Quality Management in the API or Pharma industry.
• Strong background in GxP compliance activities & ICH Q7 knowledge.
• Experience in operational management positions.

Responsabilités

• Lead the Quality department with around 90 personnel.
• Ensure compliance with Good Manufacturing Practices.
• Coordinate quality activities to meet regulatory standards.

Connaissances

Quality Management expertise

GxP compliance

Regulatory knowledge

Leadership skills

Communication skills

Strategic thinking

Formation

Professional qualification in Chemistry, Microbiology or Pharmacy

Description du poste

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. To ensure the GMP compliance, the Quality team is composed of around 90 people in 5 units : QA Production, QA Assurance, QA New Projects, Regulatory Affairs and Quality Control.

So, if you are interested by a challenging position, Join us !

Site Quality Head Responsibilities

Leading 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 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
• 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 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 & ICHQ7 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;
• 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 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.

EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe (Saint-Aubin-lès-Elbeuf and Vertolaye in France, Brindisi in Italy, Frankfurt in Germany, Budapest in Hungary and Haverhill in the UK), EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.

EUROAPI is listed on Euronext Paris.