Job Description Summary
Are you ready to lead the charge in ensuring pharmaceutical excellence? As a CQV Lead (Commissioning, Qualification, and Validation Lead), you'll play a pivotal role in bringing cutting-edge facilities and processes to life—overseeing commissioning, qualification, and validation activities that ensure compliance, safety, and operational readiness. This is a high-impact position where you'll collaborate with cross-functional teams, shape quality strategies, and drive GMP standards from concept to execution. If you're passionate about delivering robust, validated systems in a regulated environment and want to be at the forefront of innovation, this is your opportunity to make a lasting difference.
Reporting to Capital Projects Director.
The CQV Lead role will lead and coordinate the CQV project activities in line with the site procedures. The CQV Lead will work across all project functions including EHS, Quality Operations, Finance, Operations, Process Engineering, Operational Engineering, Logistics, Lean & Digital to understand their functional requirements and develop and execute the optimum validation strategy.
Responsibilities
Job Description
* Lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations.
* Support the transition to a digitized C&Q platform.
* Ensure effective resource planning is established and managed throughout the project in line with schedule and associated CQV budget including the management of CQV personnel.
* Engage at charter stage of projects to ensure proposed project schedule has been reviewed
* Manage and coordinate equipment qualification lifecycle activities, including but not limited to Factory Acceptance Testing (FAT), SAT, DQ Installation -Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
* Manage and coordinate all CQV documentation to support CQV activities
* Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
* Support continuous improvement initiatives by implementing best practices in project execution and quality assurance.
* Ensure that all stakeholders, including client teams, vendors, and subcontractors, adhere to established project protocols.
* Provide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.
Qualifications And Requirements
* Experience of managing teams or projects in a fast paced and complex environment.
* Relevant qualification (Degree) and strong experience in pharmaceutical industry commissioning and qualifying GXP systems.
* Experience in the deployment and/or extensive working knowledge/ experience of a digitized C&Q platform.
* Significant project lifecycle experience in delivering CQV for Capex projects
* Clear understanding of regulatory requirements for EU and other regulatory bodies ensuring CQV is delivered meeting all regulatory requirements and guidelines.
* Excellent verbal and written communication skills, Experience in developing a strong working relationship with other departments. Experience in presenting validation reports in quality inspections.
* Strong analytical problem-solving skills, strategic decision maker, effective planner, and ability to communicate effectively.
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.
**Additional Information*
*Relocation Assistance Provided:
No