Senior Manager - Commissioning, Qualification and Validation - all genders

As Senior Manager for Commissioning, Qualification and Validation (CQV) you will be responsible to lead the Validation team and manage the Validation program for facilities, utilities, equipment, instruments, and computer systems used for GMP manufacturing at J.POD Toulouse.  Along with your team, you will develop and implement validation plans and supporting activities for initial plant startup, new product introduction and ongoing production operations that are aligned with regulatory requirements, quality system procedures, industry standards and business objectives.  You will report to the Head of Manufacturing Science and Technology (MSAT) with dotted-line reporting to the Global Just-Evotec Head of Validation.

Responsibilities

• Provide leadership to the Validation team and management direction for the effective implementation the Validation program for facilities, utilities, equipment, instruments, and computer systems used for GMP manufacturing at J.POD Toulouse. 
• Develop and implement the Site Validation Master Plan and supporting Site Validation Project Plans for initial plant startup, new product introduction and ongoing production operations.
• Ensure Validation program delivery, performance and compliance are aligned with regulatory requirements, quality system procedures, industry standards and business objectives.
• Maintain Validation program documentation current and audit-ready.  Lead the presentation of the Validation program to auditors from health authorities, clients, and internal audit teams.
• Establish and maintain collaborative relationships with stakeholders across J.POD Toulouse.
• Measure Validation program performance and pursue opportunities for continuous improvement.
• Manage budget and manpower planning and execution for the Validation program.
• When required for the overall delivery of site Validation projects, initiate and manage contracts for 3rd party validation contract services, monitoring KPIs.
• Collaborate with Just-Evotec Global Validation to ensure alignment on program strategy and implementation.  Contribute to global Validation program initiatives where site Validation can directly contribute and benefit from the initiative.

Position Requirements :

• Master degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 10 years of experience for a Msc
• Ideally, at least 3 years of Validation leadership experience in a plant manufacturing commercial pharmaceutical products.
• In-depth knowledge of validation principles, GMP regulatory requirements and industry guidelines.
• Proven ability to lead, coach and inspire individuals and teams to set and achieve performance goals.
• Ability to get things done with the tenacity to manage change to a successful conclusion.
• Strategic thinker with a passion for improvement – allied to an execution mindset.
• Ability to think abstractly and creativity to resolve problems and achieve practical results.
• Ability to manage multiple projects simultaneously through to delivery.
• Strong business and interpersonal skills and be a persuasive communicator – written, oral and active listening - to influence peers and colleagues
• Team leadership expertise of miminum 5 years

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.