CQV Lead

X4 Life Sciences; Hessen; Hybrid; EUR 95.000 - 160.000; Vollzeit

Benefits dieser Stelle

Hybrid working model

Leadership role

Competitive salary

Zusammenfassung

X4 Life Sciences is seeking an experienced CQV Lead in the Hessen region to drive the establishment and expansion of CQV capabilities. You will lead CQV activities on major life sciences projects, providing technical leadership and coordinating with clients to ensure successful project delivery.

The role offers a hybrid working model (client sites, local offices, and remote work) and opportunities to shape a growing CQV division. Fluent German and strong team leadership are essential.

Qualifikationen

• Extensive CQV experience in pharmaceutical/biotech or life sciences.
• Proven track record leading CQV workstreams on complex capital projects.
• Experience mentoring or leading technical teams.
• Strong knowledge of GMP, GxP, FDA/EMA regulatory requirements.

Aufgaben

• Lead CQV activities on major life sciences projects.
• Act as primary technical lead for CQV workstreams.
• Build relationships with key client stakeholders.
• Support recruitment, onboarding and team development.

Kenntnisse

CQV Leadership

GMP/GxP knowledge

Stakeholder management

Team mentoring

German language

Jobbeschreibung

Industry: Pharmaceutical / Biotech Engineering

We are looking for an experienced CQV Lead to play a key role in developing our clients Commissioning, Qualification & Validation (CQV) capability in the Hesse region.

As the CQV Lead, you will be responsible for leading CQV activities on major life sciences projects while helping establish and expand their CQV division within Germany. Working closely with their clients, you will provide technical leadership, oversee project execution, and contribute to the strategic growth of the consultancy's CQV team in the region.

This role offers a hybrid working model, combining time on client sites, visits to local offices, and remote working to provide flexibility while maintaining close collaboration with clients and colleagues.

Responsibilities:

• Lead the planning, execution, and delivery of CQV activities
• Act as the primary technical lead for CQV workstreams
• Build strong relationships with key client stakeholders
• Support recruitment, onboarding, and team development
• Contribute to business growth by identifying opportunities within existing client accounts and supporting new business development activities
• Develop and implement best practices, standard operating procedures, and quality processes for the CQV function
• Ensure compliance with GMP, GxP, and relevant regulatory requirements throughout project delivery
• Collaborate closely with engineering, automation, quality, and project management teams to ensure successful project execution

Requirements:

• Extensive experience in CQV within the pharmaceutical, biotechnology, or broader life sciences sector
• Proven experience leading CQV workstreams on complex capital projects
• Previous experience managing, mentoring, or leading technical teams.
• Strong understanding of GMP, GxP, FDA, EMA, and EU regulatory requirements.
• Experience delivering qualification documentation, including IQ, OQ, PQ, and validation protocols
• Excellent stakeholder management and client-facing communication skills.
• Strong organizational and project management abilities
• Ability to work independently while leading collaborative, high-performing teams.
• Fluent German

What's on offer:

• Opportunity to build and shape a growing CQV division within an expanding engineering consultancy
• Leadership role with significant influence over team development and business growth
• Hybrid working model with flexibility between client sites, local offices, and home working
• Exposure to high-profile pharmaceutical and biotechnology projects
• Competitive salary and comprehensive benefits package