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- Tasks: Lead validation strategy and ensure compliance in a dynamic pharmaceutical environment.
- Company: Global pharmaceutical manufacturer specialising in sterile injectables.
- Benefits: Competitive salary, leadership role, and opportunities for professional growth.
- Why this job: Make a significant impact on regulatory compliance and product quality in a critical industry.
- Qualifications: 15+ years in pharmaceutical validation with strong leadership skills.
- Other info: Join a team focused on continuous improvement and operational expansion.
The predicted salary is between 72000 - 108000 £ per year.
A global pharmaceutical manufacturer specialising in sterile injectables and ophthalmic drug products is seeking a Contract Head of Validation to lead site-wide validation strategy at their North Carolina facility. The site manufactures high-quality liquid and semi-solid sterile products for regulated markets, operating within a complex GMP environment that includes aseptic processing, filling lines, sterilisation systems, clean utilities, and laboratory operations.
This is a senior leadership assignment requiring both strategic oversight and hands-on technical authority across CQV, process validation, cleaning validation, and continued process verification. You will hold ultimate accountability for validation compliance and execution across:
- Aseptic filling lines and isolator/RABS systems
- Clean utilities (WFI, clean steam, compressed gases)
- HVAC and classified cleanroom environments
- Process validation (PPQ) and cleaning validation
- Data integrity and lifecycle validation governance
Why This Role Is Critical
- The site is undergoing operational expansion and validation programme strengthening
- Regulatory expectations for sterile manufacturing continue to increase (FDA, EU GMP Annex 1 alignment)
- Strong validation leadership is required to ensure audit readiness, inspection confidence, and sustainable lifecycle control
- Failure to strengthen validation governance could expose the site to compliance risk, delayed product release, and regulatory scrutiny.
Key Responsibilities
- Own and execute the site Validation Master Plan (VMP)
- Lead and develop validation teams across CQV and lifecycle validation
- Ensure validation strategy aligns with current regulatory expectations and inspection trends
- Interface directly with QA leadership and site executive team
- Provide oversight for deviation management, CAPA effectiveness, and risk-based validation approaches
- Drive continuous improvement in validation efficiency without compromising compliance
- Act as primary validation SME during regulatory inspections
Ideal Profile
- 15+ years’ experience in pharmaceutical validation within sterile manufacturing
- Proven leadership experience as Head of Validation / Validation Director level
- Strong knowledge of aseptic processing and Annex 1 expectations
- Deep understanding of FDA inspection readiness and regulatory interaction
- Demonstrated success leading validation remediation or transformation programmes
- Confident executive presence with ability to influence cross-functional stakeholders
Validation Consultant in Tipton employer: i-Pharm ConsultingGruppe
Contact Detail:
i-Pharm ConsultingGruppe Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Consultant in Tipton
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend local pharmaceutical events. We all know that sometimes it’s not just what you know, but who you know that can help you land that Validation Consultant role.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and leadership skills. We recommend practising common interview questions related to validation compliance and aseptic processing. Show them you’re the go-to expert they need!
✨Tip Number 3
Don’t forget to showcase your achievements! When discussing your experience, highlight specific projects where you led validation strategies or improved compliance. We want to see how you’ve made an impact in your previous roles.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. Let’s get you that Validation Consultant position!
We think you need these skills to ace Validation Consultant in Tipton
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Validation Consultant role. Highlight your leadership experience in validation and any relevant projects you've led in sterile manufacturing.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for this role. Share your passion for validation and how your background aligns with our needs, especially in aseptic processing and regulatory compliance.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use metrics and examples to demonstrate how you’ve improved validation processes or led successful remediation programmes in the past.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates!
How to prepare for a job interview at i-Pharm ConsultingGruppe
✨Know Your Validation Master Plan
Make sure you’re well-versed in the site’s Validation Master Plan (VMP). Understand its key components and how they align with regulatory expectations. This will show your potential employer that you can take ownership and execute the VMP effectively.
✨Demonstrate Leadership Experience
Prepare to discuss your previous leadership roles in validation. Highlight specific examples where you led teams through complex validation processes or remediation programmes. This will help illustrate your capability to lead and develop validation teams.
✨Stay Updated on Regulatory Trends
Familiarise yourself with the latest FDA and EU GMP Annex 1 guidelines. Being able to discuss current trends and how they impact validation strategies will demonstrate your proactive approach and expertise in ensuring compliance.
✨Showcase Your Problem-Solving Skills
Be ready to provide examples of how you've handled deviations, CAPA effectiveness, and risk-based validation approaches in the past. This will highlight your ability to drive continuous improvement while maintaining compliance, which is crucial for this role.