VP, Pharmaceutical Development & Non-Clinical Quality Head

Ipsen Pharma

Multiple Locations

Job Description

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 pharmaceutical research/product development;
Proven success in developing products to EU and FDA requirements, including successful pre-approval inspections;
Proven ability to lead a team and earn respect/influence with senior colleagues in a cross-functional, international and global environment;
Excellent organizational and management skills;
Proven ability to recruit and develop skilled people and integrate into high performing teams;
Proven transfer of technologies into routine manufacturing internally or contract manufacturers;
Demonstrated leadership management experience and problem solving;
Ability to manage Critical Quality Topics by balancing all risks (Patients, Compliance, Quality, Supply, Medical);
Recognized and proven Leader who can motivate his/her people to deliver outstanding results with or without hierarchical relationships, and through well-developed emotional intelligence;
At least 15 years relevant pharmaceutical drug development experience, including oral/parenteral product development, biologics and small molecules;
Strong experience in all aspects of pharmaceutical development quality, notably with quality systems, and operational quality and Products quality;
Experience in managing quality in a multi-site, global environment.