LPO Lead for CSV & DI

Our client, a leading pharmaceutical manufacturing organization, is seeking a process owner for their site-wide quality systems. This role focuses on driving compliance and continuous improvement for validation processes while serving as a subject matter expert during regulatory inspections.

• Serve as the site-wide owner and subject matter expert for CSV and DI processes.
• Develop and oversee departmental remediation plans to ensure alignment with global regulatory requirements.
• Manage and update site-level procedures, including SOPs and work instructions, to ensure they remain effective and accurate.
• Provide technical guidance and training to site personnel on best practices and system expectations.
• Act as the primary spokesperson during internal quality reviews and external regulatory inspections.
• Maintain strategic partnerships with global process owners and quality assurance stakeholders to align on governance structures.

• You have 8+ years of experience in pharmaceutical manufacturing focusing on CSV and DI.
• You bring in-depth knowledge of FDA and EMA regulations, specifically 21 CFR Part 11, EU Annex 11, and GAMP guidelines.
• You have hands-on experience with risk-based approaches and the generation of validation documentation.
• You possess strong leadership and project management skills with experience in change management and team coordination.
• You're an expert at navigating organizational dynamics and influencing stakeholders across various levels.
• You are fluent in English.

Nice to Haves

• Experience in an API environment with knowledge of DeltaV, OSI-PI, or PCS 7.
• Working knowledge of Dutch.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.