Job Description Summary

This role is responsible for providing QA auditing for the PDx business. This role will have a focus on auditing and Global Compliance support to the GMP manufacturing sites, GDP, GPvP and GLP related functions. This role reports directly to the Sterility Assurance Director and Global Auditing Leader within Global Compliance Pharmaceutical Diagnostics.
The role will oversee, coordinate and lead audits on behalf of PDx QRA with a focus on GMP, GDP, GPvP and R&D functions. In this role insights and industry trends are to be proactively shared within PDx to ensure continued compliance and early identification of areas for continuous improvement.
This role will provide analyses of audits / trends and support in the assessment and promotion of compliance within all PDx departments including global clinical, R&D and GPvP. This role will be aware of changes to regulations, guidelines, and provide support and QA oversight for any necessary updates to operating procedures, risk assessments and change controls for process changes as well as productivity / efficiency improvement initiatives.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Responsibilities

• Manage and support a program (Plan, prepare and execute) of internal and external audits for QRA.

• Develop the program with the customer using a risk-based approach.

• Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity.

• Perform QA review and approval of audit related documents as well as PV and GLP documents within the QMS.

• Work with the customer to undertake risk analysis of systems and processes, to propose process / functional audits.

• Maintenance of the annual internal and vendor audit schedules and their updates.

• Support regulatory inspections and customer audits as a functional QA subject matter expert

• Conduct trend analysis of audit and other quality related data, provide to internal / external stakeholders as agreed

• Assure completion of vendor qualification and surveillance activities performed and documented as defined in global and functional procedures.

• Participates in the quality management system (QMS) improvements.

• Provide guidance and ensure that ‘CAPA’s are correctly set up to capture risk assessment, effective corrective and preventive actions and have the required evidence. Perform QA approvals of Quality Event records.

• Keep up to date with latest guidelines from MHRA, FDA, EMEA and other Regulatory bodies. Monitor legislation, implementing changes, and informing the company of any relevant changes.

• Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned

• Develop and manage the audit schedule throughout the year and planning for the following year

• Lead the implementation of the new TWD Audit module and be the SME for ongoing updates / improvements

• Coaching others to gain inspection / auditing experience

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 work with global, cross-functional teams

• Proven ability to drive operational excellence

• Ability to travel

Desired Skills

• Previous Auditing experience required.

• Knowledge of cGMP, GDP, GPvP and GLP required

• 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

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