Senior Validation Manager

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Baxter has an exciting opportunity for a Senior Validation Manager to join our Compounding team covering EMEA (UK, Ireland, Italy and France).  We are looking to speak with candidates that have a proven ability to develop and coach a team with a solid background in quality/validation. This role can be based at any of our UK sites (Thetford, Croydon, Stockport or Oxford).

Initially to develop rapport and meet with stakeholders you will travel to all sites but as you become settled the role will be 20% travel (expected in total 1 week of the month). This role comes with car allowance and a 15% bonus.

The Senior Validation Manager will lead and oversee all Validation activities to ensure compliance within Baxter Healthcare EMEA Compounding with regard to regulatory and internal expectations and provide a service to EMEA compounding for the validation of new and existing processes/equipment/systems by developing and maintaining plans providing visibility of key validation requirements.

You will act as a valuable and effective source of information and advice as a subject matter expert on this area and will positively contribute to the EMEA Compounding Management Team.

Benefits of joining Baxter

• 25 days annual leave + bank holidays
• 15% MICP bonus
• Employee discount scheme
• Blue light card
• Progression opportunities company wide
• Westfield healthcare
• Up to 8% pension contribution

Essential duties and responsibilities:

• Develop, implement, and maintain the EMEA Validation program in accordance with regulatory requirements, company requirements and industry standards, coordinating the country’s dedicated validation resources to ensure that the Validation Master Plans are adhered to across EMEA compounding by working with quality, engineering and production teams
• Act as subject matter expert (SME) on validation matter and on validation projects across multiple sites:
  • Providing technical consultation and support for VMP-VP, URS/FAT/SAT, IQ/OQ/PQ protocols in case of high relevant cases/projects
  • collaborating with cross-functional teams to ensure validation activities are compliant and integrated in the schedule or project timeline
  • Ensuring technical consultation on requests in case of qualification and audit of external suppliers of equipment & technical services
  • Providing technical input on Change Control evaluations with regards to Qualification and Validation aspects

• Ensure visibility on local/country state of Compliance by regular monitoring, tracking actual plan vs VMP, CMP schedule - KPI reporting
• Provide training, guidance and development plan for validation team members
• Ensure technical input and guidance on deviation investigations during qualification/validation activities and/or for root cause analysis and corrective actions validation related.
• Participate in audits and inspections, preparing necessary documentation and responding to questions from regulatory authorities.
• Identifying opportunities for improving equipment and methods: actively supporting the compounding organization on identification/implementation of new technologies.
• Lead the EMEA Validation project portfolio (Capital Expenditure and Process Improvement) and create business cases required to justify capital investment for process automation and redesign

Experience required:

• Good Leadership and Management skills with proven experience leading validation projects and managing validation teams.
• Strong planning, organisational and time management skills along with the ability to make decisions, solve problems and think critically
• Knowledge of pharmaceutical manufacturing equipment & processes controls, Computerized systems validation and automation knowledge
• Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
• Well-developed verbal, written, numeric and presentation skills
• Bachelor's degree in a relevant field (e.g., Chemistry, Pharmacy, Biology, or related sciences). A Master's degree or higher is preferred.
• Extensive hands-on experience in Pharma Validation and/or Quality areas (experience in Qualification/Validation of Isolators equipped with VHP technology is a plus). (Qualification & Validation/ Quality Management System - Quality Risk Management – Change Control / Aseptic Manufacturing/ Isolator Technology – VHP Sanitization/ Project Management
• Lead roles in Pharma, with specific exposure to sterile aseptic manufacturing

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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