Job Description SummaryThe Global Compliance Quality Assurance R&D / GCP Leader is a crucial role within clinical research, particularly in the pharmaceutical, biotechnology, or medical device industries. This individual is responsible for overseeing the quality assurance processes related to clinical trials to ensure compliance with GCP standards, regulatory requirements, and company policies. Here are some key responsibilities associated with this role:This role is responsible for providing Leadership and QA oversight to the PDx R&D & GCP activities / programs. 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 Senior Director Global Compliance and Quality Systems Pharmaceutical Diagnostics.The role will oversee inspections, compliance and program 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 DescriptionKey responsibilities/essential functions include:
Team Leadership: As a team leader, you would be responsible for leading a team of quality assurance professionals who are involved in monitoring and auditing clinical trials. This includes assigning tasks, providing guidance and support, and ensuring that team members are adequately trained.
Quality Assurance Planning: Develop and implement quality assurance plans for clinical trials, outlining the processes and procedures to be followed to ensure compliance with GCP standards and regulatory requirements.
Risk Assessment and Mitigation: Conduct risk assessments to identify potential areas of non-compliance or risks to the integrity of clinical trial data. Develop strategies to mitigate these risks and ensure the quality and reliability of trial results.
Monitoring and Auditing: Oversee monitoring and auditing activities conducted by the quality assurance team to evaluate compliance with GCP standards, study protocols, and regulatory requirements. This may include on-site visits to clinical trial sites to conduct audits and inspections.
Documentation and Reporting: Ensure that all quality assurance activities are properly documented and reported in accordance with company procedures and regulatory requirements. This may involve preparing audit reports, documenting findings and observations, and tracking corrective and preventive actions.
Training and Education: Provide training and education to clinical trial staff on GCP standards, regulatory requirements, and company policies related to quality assurance. This helps to ensure that all personnel involved in clinical trials are aware of their responsibilities and understand the importance of compliance.
Continuous Improvement: Continuously evaluate and improve quality assurance processes and procedures to enhance the efficiency and effectiveness of oversight activities. This may involve implementing new tools or technologies, updating standard operating procedures, and incorporating best practices from the industry.
Stay Updated with Regulations: Stay abreast of updates to relevant regulations, guidelines, and industry best practices to ensure ongoing compliance and adaptation of quality assurance processes
Overall, the role of a GCP Quality Assurance Oversight Team Leader is critical for maintaining the integrity and reliability of clinical trial data and ensuring the safety and well-being of study participants. It requires strong leadership, attention to detail, and expertise in GCP standards and regulatory requirements.
Desired Characteristics:
Previous Quality Assurance experience required.
Extensive People Leader experience
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 leadership skills
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.#LI-remote#LI-DG1Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf) . 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.GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.Relocation Assistance Provided: No
