Vp, Pharmaceutical Development

il y a 4 jours

BoulogneBillancourt, France Ipsen Pharma (SAS) Temps plein

As part of the Global Quality organization, you actively contribute to the strategy to become a center of excellence in the development of biologics, small molecules, and medical devices.

You build, lead, and continuously improve
- an effective global **Pharmaceutical Development Quality** organization across the 4 Pharm Dev sites that ensures the quality of Ipsen Investigational Medicinal Products (IMPs) including their end-to-end supply chain, guaranties that patient’s interests are met,
- an effective **Non Clinical Quality** organisation supporting Research, external innovation and early development.

Main responsibilities and duties
- Design and lead a global organization to provide adequate Quality support to all pharmaceutical development and early development functions based in different sites,
- Ensure compliance to regulations of all Quality systems (GMP, GLP, GCLP) including for inspection readiness in collaboration with the local Tech Ops Quality Teams if relevant with some sites,
- Establish and ensure that appropriate Quality standards are applied to the products and to the Manufacturing (specific to Investigational Medicinal Products and Non-clinical Products) and Development Operations in accordance with Regulatory requirements and Global Quality Standards,
- Ensure Quality and compliance oversight of service providers, third parties, CDMOs of Early and Pharmaceutical development,
- Recruit, lead, manage and develop people, to ensure that the Pharmaceutical Development and Non-clinical Quality team as a whole and as individuals have the necessary skills, knowledge experience, motivation, and empowerment to perform their roles,
- Develop a strong partnership between the Quality team and the Pharmaceutical Development and Early development functions to ensure the continuous improvement of Ipsen QMS and its successful deployment across relevant functions,
- As a member of the Pharm. Dev Leadership Team, provide input to the development and delivery of site strategy and goals, promoting cross-functional working and Enterprise Excellence,
- Be an active member of the Quality Leadership Team (QLT) and contribute to the strategy, objectives, and activities of the QLT,
- Enhance the reputation of IPSEN with external partners, authorities, and the general public.
- Ensure proper Quality evaluation for Early and pharmaceutical development during the due diligences and /or the transitions periods.
- Define annual objectives for his / her organization and for each member of his / her direct report, aligned with Pharm. Dev, Early Development and Global Quality objectives.
- Manage his / her team with strong common objective commitments,
- Ensure a suitable level of communication within his / her team,
- Perform appraisal for each member of his / her report line and make sure that individual development of his / her staff is addressed,
- Be responsible for the annual compensation review process, recruitment, and for defining the training plan for each member of his / her team,
- Develop a strategic Quality plan for the Pharm. Dev organization and Early Development, ensure its implementation,
- Develop, track, and communicate global KPIs for the continuous improvement of Quality performance and compliance across all relevant sites and functions. Ensure these objectives are met and that continuous improvement is demonstrated.
- Ensure the Quality review, release and disposition of Finished Investigational Medicinal Products (locally manufactured or subcontracted out), APIs, Raw Materials and components in collaboration with TechOps Quality organisations if relevant.
- Ensure Quality regulatory support for the DS/DP batch compliance according to regulatory dossiers and for batches release.
- Ensure Quality relationship with Ipsen strategic partners in the context of Product and Device Development & IMPs supply,
- Ensure the availability and implementation of appropriate GxP training programs for the staff,
- Ensure the development and efficient operation of the Pharm. Dev Quality systems, particularly concerning deviations (Unplanned Events, Out Of Specifications), Internal and External Audit, Change Control, Complaints, Documentation, Validation & Qualification in conjunction with TechOps Quality organisations if relevant,
- Ensure an effective local and global Quality Management Review process is in place,
- Contribute to the development of Global Quality policy and strategy, and to the installation of best practices worldwide, as part of the Global Quality functional team,
- Encourage best practices, ways of working, specifically encouraging the use of Enterprise Excellence risk management and continuous improvement. Promote a site culture of total Quality and of cost-effective Quality.

Experience
- Proven experience in managing complex technology projects would be an advantage,
- Significant experience in managing and leading technical functions within matrix and cross-functional teams within pharmac

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