At a Glance
- Tasks: Lead global validation strategies in pharmaceutical manufacturing and ensure compliance with industry standards.
- Company: Join a leading pharmaceutical company focused on quality and innovation.
- Benefits: Enjoy competitive pay, generous leave, healthcare plans, and employee perks.
- Other info: Be part of a culture that promotes quality, compliance, and continuous improvement.
- Why this job: Make a significant impact in a dynamic environment while advancing your career.
- Qualifications: Degree in relevant field or 10 years of industry experience required.
The predicted salary is between 63000 - 77000 £ per year.
We are seeking an experienced and strategic Head of Validations to lead our global validation function across our pharmaceutical manufacturing operations. Reporting to the Director of Quality and R&D, this senior role is responsible for developing and implementing validation strategies for aseptic processing, sterilisation, and equipment qualification across all manufacturing sites. The role is also responsible for overseeing GxP Computerised System Validation activities, ensuring a high-performing Validation team that supports manufacturing operations while maintaining regulatory compliance.
Main Activities/Tasks
- Provide strategic and technical leadership for validation activities across global manufacturing sites.
- Develop, implement and continuously improve the company's validation master strategy for:
- Equipment qualification
- Facilities and utilities qualification
- Sterilisation validation
- Aseptic processing validation
- GxP Computer Systems Validation (CSV)
- Ensure validation programmes comply with current GMP, international regulatory requirements and recognised industry standards.
- Lead the development, review and approval of validation policies, procedures, protocols and reports.
- Act as the company Subject Matter Expert (SME) for validation and CSV during regulatory inspections and customer audits.
- Drive continuous improvement of validation systems, ensuring efficient delivery while maintaining compliance.
- Collaborate with Engineering, Manufacturing, Quality, IT and Regulatory Affairs on new capital projects, equipment installations, facility expansions and system upgrades.
- Provide expert input into change control activities to ensure validation requirements are appropriately assessed and executed.
- Develop validation strategies for new technologies, digital systems and manufacturing improvements.
- Identify training needs across the business and deliver or coordinate validation-related training.
- Monitor departmental KPIs, validation schedules and resource planning to ensure projects are delivered on time and in compliance.
- Promote a strong culture of quality, compliance and continuous improvement throughout the organisation.
- Ensure all Health & Safety policies and procedures are followed within the department.
- Participate in wider Quality and business improvement initiatives as required.
Essential Criteria:
- Degree, or equivalent qualification, in Pharmaceutical Sciences, Engineering, Microbiology, Biotechnology, Chemistry or a related discipline, or at least 10 years relevant industry experience.
- Significant experience within the pharmaceutical or sterile manufacturing industry, operating within GMP regulated environments.
- Extensive experience leading validation programmes covering equipment, facilities, utilities, sterilisation, aseptic processing and GxP Computer System Validation.
- Proven leadership experience managing multidisciplinary technical teams.
- Strong working knowledge of US and EU GMP requirements, including EudraLex Annex 1 and Annex 11.
- Strong project management and organisational skills with the ability to prioritise multiple projects and deliver to challenging deadlines.
Desirable Criteria:
- Experience leading a global or multi-site pharmaceutical validation function.
- Knowledge of industry standards for validations such as ISPE, BS/EN, GAMP 5, ASTM etc.
- Previous project participation in introducing new equipment facilities and systems, or modification of existing systems.
- Participation in EU or US regulatory audits.
- Lean Six Sigma or equivalent.
Benefits:
- Free life assurance
- Pension salary sacrifice scheme with 5% employer contribution
- Healthcare cash plan
- 32 days annual leave (increasing with length of service)
- Wedding leave
- Enhanced Maternity / Paternity Pay
- Company Sick Pay
- Subsidised Canteen Facilities
- FREE On-site parking
- Cycle to Work Scheme
- Tech Purchase Scheme
- Free Will-Writing Service
- Employee perks/discounts scheme
- Employee Assistance Programme (EAP)
- Employee well-being initiatives
- Employee recognition scheme
To Apply
Please forward your CV via the APPLY Now button below.
Head of Validations TLNT1_NI in Newry employer: Norbrook
As an MS&T Site Manager at our Newry location, you will be part of a dynamic and supportive work culture that prioritises employee development and safety. We offer competitive benefits, including opportunities for professional growth and a commitment to maintaining the highest quality standards in manufacturing. Join us to make a meaningful impact while enjoying a collaborative environment that values innovation and teamwork.
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We think you need these skills to ace Head of Validations TLNT1_NI in Newry
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Norbrook!
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Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Norbrook!
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How to prepare for a job interview at Norbrook
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Norbrook that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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