Good Clinical Practice (GCP) Senior Quality Assurance (QA) Vendor Management Oversight

Job Description Summary
The Good Clinical Practice (GCP) Senior Quality Assurance (QA) Vendor Management Oversight role plays a critical role in ensuring the quality, integrity, and compliance of clinical trials conducted by pharmaceutical, biotechnology, and medical device companies. Vendors are third-party organizations or individuals that provide services or support to sponsors in conducting clinical trials, such as contract research organizations (CROs), central laboratories, imaging centers, and data management companies. This role is responsible for providing QA oversight to the PDx R&D & GCP Vendor activities. This role will have a focus on Global Compliance support to R&D & GCP activities but also to the GMP manufacturing sites, GDP, PV, and GLP related functions. This role reports directly to the Global Compliance Quality Assurance R&D / GCP Leader Pharmaceutical Diagnostics.
The role will oversee vendor compliance related activities on behalf of PDx QRA with a focus on GCP and R&D functions including to but not limited to CRO’s, Investigator sites, Centralised Labs and specialist Non Clinical Labs. 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 trends and support in the assessment and promotion of compliance within all PDx departments including global clinical, non clinical and R&D. 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.
Job Description
Key responsibilities/essential functions include:

• Vendor Selection: Sponsors should carefully select vendors based on their expertise, capabilities, experience, and compliance with regulatory requirements. This process involves conducting due diligence, evaluating vendor qualifications, and assessing their track record in delivering high-quality services.
• Vendor Qualification and Auditing: Sponsors should ensure that vendors are qualified and have appropriate quality management systems in place to meet regulatory requirements. This may involve conducting vendor audits or assessments to evaluate their processes, procedures, infrastructure, and personnel qualifications.
• Vendor Oversight Plan: Sponsors should develop a comprehensive vendor oversight plan that outlines the responsibilities, expectations, and communication channels between the sponsor and vendors. This plan should include key performance indicators (KPIs) and metrics for evaluating vendor performance, as well as mechanisms for addressing issues or deviations from the plan.
• Monitoring and Quality Assurance: Sponsors should actively monitor vendor performance throughout the duration of the clinical trial to ensure compliance with GCP, protocol requirements, and regulatory standards. This may involve reviewing study data, conducting site visits, and participating in regular meetings with vendors to discuss progress and address any concerns.
• Risk Management: Sponsors should identify and assess potential risks associated with vendor activities and implement strategies to mitigate these risks. This may include developing contingency plans, establishing clear communication channels, and providing ongoing training and support to vendors.
• Documentation and Record Keeping: Sponsors should maintain accurate and complete documentation of vendor activities, including contracts, agreements, correspondence, and audit reports. This documentation serves as evidence of compliance with regulatory requirements and may be subject to inspection by regulatory authorities.
• Overall, effective vendor management oversight is essential for ensuring the quality, integrity, and compliance of clinical trials and ultimately protecting the rights and safety of study participants. Collaboration, communication, and proactive risk management are key principles in establishing successful partnerships with vendors and achieving the objectives of clinical research programs.
  

Desired Characteristics

• Previous Quality Assurance & Vendor Management experience required.
• Knowledge of cGMP, GCP 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
  

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 work 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, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviours: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
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