You lead and coordinate CQV programs across sites, ensuring compliance and enhancing technical capabilities while managing vendor relationships and driving innovation in practices.
Anforderungen
- •Degree in Engineering or equivalent discipline.
- •15+ years of experience in GMP-regulated manufacturing.
- •Minimum 8 years of leadership experience.
- •Deep knowledge of CQV methodologies.
- •Proven ability to influence cross-functional teams.
- •Excellent problem-solving and analytical skills.
- •Effective communicator of complex technical information.
- •Experience managing external vendors.
- •Strong business acumen with understanding of trade-offs.
- •Fluent in English; additional language skills a plus.
Deine Aufgaben
- •Lead CQV programs across regional sites.
- •Ensure consistency in Site Validation Master Plans.
- •Build technical CQV capabilities within site teams.
- •Provide leadership to engineering and quality teams.
- •Manage contractors and vendors for CQV services.
- •Drive inspection readiness for regulatory compliance.
- •Collaborate on SOPs and CQV practices across technologies.
- •Identify and implement CQV innovations and best practices.
Original Beschreibung
# OpU Lead, Commissioning & Qualification
**Zurich, Switzerland** | **Full time**
## Job Description
**About the Role**
As OpU Lead for Commissioning & Qualification (CQV), you will shape and drive Takeda's CQV strategy across a network of manufacturing sites, ensuring alignment with ASTM E2500, regulatory expectations, and operational excellence. You will lead the development of core CQV competencies, manage vendor performance, and implement best-in-class standards that support Takeda’s ambition to deliver high-quality therapies to patients worldwide.
**How You Will Contribute**
* Lead and harmonize CQV programs across sites in the region to ensure alignment with global validation frameworks and ASTM E2500 principles.
* Ensure consistency in Site Validation Master Plans and requalification programs in compliance with regulatory and internal standards.
* Build and nurture technical CQV capabilities across site teams, fostering knowledge retention and SME development.
* Provide leadership and technical direction to site engineering and quality teams on CQV execution.
* Manage contractors and external vendors, ensuring quality delivery of CQV services aligned to Takeda’s expectations.
* Drive inspection readiness and ensure CQV-related contributions to regulatory responses are robust and compliant.
* Collaborate cross-functionally across technologies (Plasma, Biologics, Small Molecule, API) to align on SOPs and CQV practices.
* Identify and implement CQV innovations, benchmarking industry best practices and contributing to Takeda's innovation roadmap.
**What You Bring to Takeda**
* Degree in Engineering (Mechanical, Chemical, Process) or equivalent technical discipline.
* 15+ years of experience in GMP-regulated pharmaceutical manufacturing with strong CQV expertise.
* Minimum 8 years of leadership experience in a matrixed, global organization.
* Deep knowledge of CQV methodologies, including computer system validation, and regulatory frameworks (GxP, FDA, EMA, etc.).
* Proven ability to influence and lead cross-functional and cross-cultural teams at global and site levels.
* Excellent problem-solving, analytical, and strategic thinking skills.
* Effective communicator with the ability to translate complex technical information to stakeholders at all levels.
* Experience managing external vendors and negotiating service contracts.
* Strong business acumen, with understanding of cost, quality, and risk trade-offs.
* Fluent in English (oral and written); additional language skills a plus.
## Locations
Zurich, Switzerland
## Worker Type
Employee
## Worker Sub-Type
Regular
## Time Type
Full time