Quality Validation SME – Transport & CMO Products

Our client, a leading life sciences organization, is seeking an expert to oversee validation activities for transport and CMO-manufactured products. This role ensures the compliance of validation lifecycles, protocols, and risk assessments while serving as a key technical point of contact for regulatory submissions and audits.

• Develop, review, and approve transport validation plans, protocols, risk assessments, and reports for global distribution.
• Oversee external qualification and validation packages provided by contract manufacturing organizations (CMOs) to ensure adherence to corporate standards.
• Perform validation impact assessments for change controls, deviations, audit findings, and corrective actions (CAPAs).
• Support process validation and continued process verification (CPV) strategies for outsourced products.
• Represent the organization as a technical expert during health authority inspections and internal quality audits.
• Collaborate with cross-functional core teams to ensure validation milestones are met within project timelines.

• You have 8+ years of experience in validation and qualification, with a focus on equipment qualification, requalification, and shipping validation.
• You possess expert knowledge of the Validation Lifecycle Approach and risk-based validation methodologies.
• You bring extensive experience working within cGMP, ISO 13485, and MDSAP regulatory frameworks.
• You demonstrate strong interpersonal, negotiation, and project management skills to lead complex cross-functional initiatives.
• You are fluent in English with excellent written and oral communication skills.

Nice to Haves

• Strong digital proficiency and experience with automated validation tools.
• Experience acting as a process owner within a global community of practice.

• 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.