Job Description SummaryThe Global QMS Excellence Leader is responsible for the management and development of key QMS Programs and generating the new standard for QMS records within Pharmaceutical Diagnostics (PDx). This role reports directly to the Senior Director Global Compliance & Quality Systems PDx.

This role will own the strategy and implementation of QMS improvement programs for example setting the standard for QMS records (Deviations & CAPAs), the development of a refreshed QMS training – how to conduct a root cause analysis & associated tools, Human Error prevention standards and training and Technical writing for effective investigations. This will include the development and implementation of new tools and new processes which will be rolled out globally to all functions within the PDx business.

This role will be responsible for further improvements and development of TrackWise Digital QE & CAPA workflows and design. Any update to the training for these modules will be under the responsibility of this role.

This role will support the development of the Quality Culture / Quality Management Maturity model for PDx. This role will also be responsible for developing standardised processes with the aim to eliminate rejection of records and rework getting us to a higher level of “Right First Time”.

Job DescriptionKey responsibilities

Responsible for the generation, planning and overall execution of the Global QMS Excellence strategy

Responsible for the generation, planning and overall execution of new standardised processes starting Root Cause Analysis tools and “how to conduct an investigation”.

Develop the strategy and execute the roll out of the Human Error identification & prevention / HOP processes and training / education.

Define a new strategy to improve the update and adoption of Global Procedures with the removal of Local procedures which have the potential to drift from the global standard.

Define the standard of Technical writing of investigations and develop training approach to improve this across PDx.

Develop a program to facilitate a “Right First Time” approach – check lists, standardised approach, key thing to consider etc. to improve the current metrics.

Develop a new set of metrics to manage and monitor QMS records with the support of the Global Data Analyst and roll out to all departments. This should include but is not limited to Right First Time / Reject rates for records, Closed on time vs. Closed late, Number opened vs. closed in a period to assess loading and resource requirements, level loading of resources etc.

Lead the knowledge increase of the QMS systems to non GxP personnel and provide coaching to all Leads across the PDx supporting functions.

Develop continuous improvement processes to ensure that the overall QMS remains current and is aligned to the regulations

Be available to support all regulatory and internal audits across PDx as the PDx Global QMS SME

Liaise with all levels of the organization on QMS matters including QMRs.

Holistically review the QMS and provide feedback of key updates and continuous improvement opportunities

Keep up to date with latest guidelines from MHRA, FDA, EMEA and other Regulatory bodies

Desired Characteristics

Previous QMS experience required and in-depth knowledge of cGMP requirements.

Demonstrated experience with applying Quality tools and knowledge of regulations and guidelines.

Experience interfacing with global regulatory agencies.

Ability to comprehend and communicate key regulatory requirements and expectations

Experience of collaboration, negotiation & conflict resolution skills

Proven leadership skills (experience successfully managing people/projects/issues)

Change agent with energy, passion & enthusiasm to drive change

Demonstrated effective interpersonal, teamwork & networking skills

Demonstrated ability to lead teams across poles, cultures, sites

Ability to detect trends, shifts in requirements and align internal organisation priorities and actions accordingly

Ability to influence. Determine a position and argue it effectively within the business context

Required Qualifications:

Bachelor's degree and extensive experience within the pharmaceutical industry

Strong communication skills

Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities

Superior ability to lead change with global, cross-functional teams

Proven ability to drive operational excellence

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

Relocation Assistance Provided: No