Global Head Commissioning, Qualification & Validation (CQV)

Job Description Summary

As the Global Head of Commissioning, Qualification & Validation, you will be responsible for developing, leading and providing oversight to the commissioning, qualification and validation (CQV) activities for Capital Projects, and Continuous Lifecycle Verification within PDx segment of GE Healthcare. The role involves ensuring, that PDx has appropriate business processes in place to ensure our facilities and equipment can be properly commissioned and validated to meet business and regulatory requirements. They shall lead the business transformation across our sites as we transition to a Lean Risk based CQV for manufacturing and associated computer systems validation within a Digitized C&Q Platform. They shall work closely with site CQV Leaders and interface with Functions, (Project Management, Quality, Engineering, Lean & Digital and EHS) as well as External Project Partners (Engineering, Construction Management and Qualification Service Providers) to ensure successful implementation of a Lean CQV strategy on project delivery and in continuous operations.

Job Description

Responsibilities

• Lead delivery of CQV for the PDx portfolio of projects across our Contrast Media and Molecular Imaging to ensure successful delivery of capital projects, safely, to the right quality within cost and schedule constraints.

• Ensure robust and Lean Commissioning & Qualification systems, Site Master Validation plans, methods and tools in place for operational Lifecycle and Continuous Verification C&Q on sites.

• Drive the adoption of Risk based Commissioning & Qualification and implement continuous improvements and innovations to ensure PDx is aligned with best practice and latest regulatory requirements.

• Drive the transformational rollout, implementation and adoption of digitized C&Q

• Lead implementation of Computer Systems Validation for Manufacturing Facilities on our sites and supporting Process Automation systems

• Credibly present and defend the validation status as appropriate to external and internal auditors and agencies.

• Ensure on projects, the creation and implementation of appropriate CQV strategy and project planning and resourcing, aligned with design and construction sequencing and key functions.

• Lead stage gate reviews of projects in planning and execution phases to ensure strategy, timelines, sequences, resources are optimised for successful project delivery

• Ensure on projects that an appropriate handover strategy to end users is developed and ultimately delivered. This shall include training, document handover, operation strategy.

• Develop the CQV network and capabilities across PDx

Required Qualifications

• Relevant qualification (Degree) and significant experience in pharmaceutical industry commissioning and qualifying GXP systems.

• Certification in project management (PMP or equivalent) is a plus.

Desired Characteristics

• Proven track record of managing large-scale C&Q programs from design phase through to closeout and handover.

• Multi-regional / Global experience

• Global and enterprise-wide mentality coupled with strong communication skills (verbal & written), and the ability to articulate ideas to influence different levels of leadership ensuring alignment of C&Q methodologies across projects and sectors

• Proven knowledge of C&Q methodologies and the current industry requirements

• Experience in the deployment and/or extensive working knowledge/ experience of a digitized C&Q platform.

• Clear understanding of regulatory requirements for EU, China and US regulatory bodies in particular ensuring CQV is delivered meeting all regulatory requirements and guidelines.

• Strong analytical problem-solving skills, strategic decision maker, effective planner, and ability to communicate effectively.

• Strong capability to collaborate with and influence technical leaders across different PDx segments and functions, as well as external project partners (Engineering, Construction firms, C&Q partners, etc.)

• Location Cork, Lindesnes, Oslo. Mix of On site and hybrid

• Some International travel is likely in this role potentially including weekends and multi-week stays. Travel of approximately up to 20% away from home

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information