Mgr Quality Validation (Raleigh, US

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

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Lead the Validation Team to provide excellent service to customers and ensure compliance to cGMP FDA/EMEA regulations. Serve as a Validation subject matter expert, track, and report action plan status/ completion as it relates to validation systems improvement efforts. Responsible for managing the development and the execution of qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities, facilities, manufacturing, and cleaning processes.

Support ongoing site wide projects by collaborating with experienced members of the Engineering, MS&T, Operations and QA teams to identify roadblocks and additional efficiencies. Additional daily responsibilities include performing and documenting risk assessments of systems and processes, assessing change proposals, drafting/reviewing/approving protocols, and reports, evaluating deviations/change controls and initiating revisions of GMP documentation related to validation.

Essential Functions

• Responsible for the day-to-day activities conducted by the Validation department.
• Provide leadership on the activities of the internal validation staff as well as external validation contractors.
• Lead team member assignments to assure tasks are completed accurately and to schedule.
• Establish priorities to ensure that deadlines are met, and budgets are not exceeded.
• Oversee the site Validation Master Plan, using input from internal and external resources for continuous improvement.
• Create, coordinate, maintain and enforce Validation systems, policies, and procedures.
• Participate in audits and inspections conducted by internal and external entities.
• Able to correctly assess all change controls with an accurate understanding of the bigger picture implications of changes
• Review and approve all business unit validation testing and documents for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data.
• Ensure all revalidation requirements are met for equipment, process, and cleaning site wide.
• Manage the revalidation program.
• Team member for new product introductions, regulatory compliance initiatives, implementation of process improvements.
• Forecast and manage project work correctly and independently; able to be an independent interface to other portions of the organization as assigned, providing updates as requested and seeking out higher level input when it is necessary; scope of projects managed is large and complex.
• Write and review policies or procedures for compliance with regulatory guidance.
• Active leader and decision maker, as needed, on internal projects related to formulation, filling, environmental, facility improvements and developing new approach to business.
• Work with Regulatory Affairs to prepare Regulatory Submission Documents for project initiatives.
• Lead initiatives to streamline processes and workflow by initiating Operational Excellence initiatives.
• Interact with management, senior management, and stakeholders to determine project scopes, timelines, and prioritization of global and local projects.
• Manage validation activities for large scope capital projects (including Turnaround projects) that encompass multiple protocols and/or a validation plan.
• Direct supervision of contractors or other specialists.

Key Requirements

• Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities, classified facilities, cleaning, and Process Validations.
• Thorough knowledge of the of steam sterilization, cleaning and process validation and equipment qualification.
• Strong leadership skills, the ability to prioritize, multitask and work efficiently in a dynamic, ever changing manufacturing environment.
• Perform administrative duties associated with managing a department and staff. (i.e. establish group goals, and performance reviews).
• Strong coaching and mentoring skills and a track record of developing direct reports.
• Identify quality issues, and in…