Overview
Validation & Quality Lead (Pharma / Life Sciences) Jobs in Greater Bern Area at PQE Group
Title: Validation & Quality Lead (Pharma / Life Sciences)
Company: PQE Group
Location: Greater Bern Area
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
We are seeking a highly experienced Validation & Quality Lead with over 10 years of experience in the Pharma and Life Sciences industry. This role combines strategic oversight of validation activities with leadership responsibility for quality governance, ensuring compliance, consistency, and excellence across complex programs.
The Validation & Quality Lead will be responsible for the end-to-end oversight of validation and quality processes across regulated environments. Acting as a key interface between project delivery, quality, and executive stakeholders, the role ensures alignment with regulatory requirements and organizational objectives.
This position is part of a long-term project based in the Canton Bern (Switzerland) and requires 100% on-site presence.
Responsibilities include, but are not limited to:
Validation Lead Responsibilities
• Provide oversight of Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities
• Define and implement validation strategies aligned with regulatory expectations and project goals
• Oversee deviation management and CAPA processes, ensuring timely resolution and compliance
• Coordinate review and approval of validation deliverables (e.g., URS, FS, DS, IQ/OQ/PQ, RTM)
• Manage and ensure compliance across the system lifecycle, from implementation through maintenance
• Maintain and govern system inventories, ensuring accuracy and audit readiness
• Establish and enforce validation governance frameworks, policies, and standards
Quality Lead Responsibilities
• Act as the primary organizational interface in close collaboration with the Project Manager
• Lead monthly Steering Committee meetings, including reporting to executive stakeholders
• Provide weekly operational status updates, including KPI tracking and dashboard reporting
• Establish and manage a formal issue escalation matrix, including defined resolution timelines
• Develop and maintain a resource management plan to ensure continuity across all project phases
• Conduct and oversee annual performance reviews against contracted SLAs and KPIs
Required Qualifications:
• 10+ years of experience in Validation and/or Quality roles within Pharma, Biotech, or Life Sciences
• Strong expertise in CSV, CSA, GxP, GMP, and relevant regulatory standards (FDA, EMA, Annex 11)
• Proven experience in validation strategy development and governance
• Demonstrated ability to manage complex programs and senior stakeholders
• Experience with systems such as MES, LIMS, ERP, DCS, or PCS
• Strong leadership, communication, and stakeholder management skills
• GAMP 5 knowledge or certification is highly desirableFluent in German and English
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
