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General Electric Global Data Integrity Manager, PDx in Chalfont St Giles, United Kingdom

Job Description Summary

As a Global Data Integrity (DI) Manager, you will be responsible for the strategic development of the DI Program for Pharmaceutical Diagnostics. You will own the strategy and implementation of the DI program and develop the governance to ensure effective program execution.

You will also lead the PDx team in the implementation of GxP Data Integrity requirements against Best Practice. This includes developing global policies and procedures that comply with the worldwide GxP guidelines and to enforce Best Practices with respect to paper documents, computerised systems and processes. As a Global Data Integrity Manage, you will report directly to the Senior Director Global Compliance Pharmaceutical Diagnostics.

Job Description

Responsibilities

  • Responsible for the generation, planning, and overall execution of Global Data integrity strategy

  • Lead the knowledge increase for the DI leads and provide coaching to all DI leads and the PDx sites

  • Be available to support all regulatory audits across PDx specifically as the PDx DI Global SME

  • Manage and support a program of internal audits of all Data integrity processes using a risk-based approach. Ensure all identified actions are completed in a timely manner

  • Liaise with all levels of the organization on DI matters

  • Work in collaboration with the site DI leaders to deliver the Data Integrity program

  • Drive, monitor and report progress against the DI site strategy and program. Responsible for resolving issues and managing escalation to PDx senior management team

  • Provide guidance and ensure that system or equipment ‘CAPA’s are correctly set up to capture risk assessment actions.

  • Holistically review remediation actions and specifically the “CAPAs” when complete to ensure effective – providing feedback to the sites and the core PDx DI team to ensue effective communication and learning

  • Develop a standardized approach for the use, storage, maintenance and validation of GxP Spreadsheets

  • Identify deficiencies in documentation or best practice and to organise remedial action to bring processes into line with guidelines

  • Support PDx sites in developing standards for DI requirements in project documentation, including URS, Tender documentation, supplier responses and supplier audit details in relation to data integrity compliance and compliance with policies and standards. Act as Global DI SME reviewing major project documentation

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

  • Manage data integrity training by designing, delivering and maintaining training packages with the support of the Global PDx training group.

  • Support the Global CSV strategy

Qualifications and experience

  • Bachelor's degree (or equivalent) in related field

  • Significant business experience

  • 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

Desired Skills

  • Previous Data Integrity experience required

  • Knowledge of Computer System Validation desired

  • Extensive experience in the Pharmaceutical industry

  • Demonstrated experience with applying classic Quality tools

  • 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

Eligibility requirements

A good level of English and a valid work permit

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.

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

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