The Good Clinical Practice (GCP) Quality Assurance (QA) Oversight role is crucial in ensuring that clinical trials are conducted in compliance with regulatory requirements, protocols, and standard operating procedures (SOPs). This role is responsible for providing QA oversight to the PDx RD GCP activities / programs. This role will have a focus on Global Compliance support to RD 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 RD / GCP Leader Pharmaceutical Diagnostics.

The role will oversee compliance and program related activities on behalf of PDx QRA with a focus on GCP and RD 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 RD. 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

• Compliance Monitoring: The QA Oversight role involves monitoring and assessing compliance with GCP regulations, as well as applicable local and international regulatory requirements. This includes ensuring that all activities related to the conduct of clinical trials adhere to the principles of GCP.
• Audit Planning and Execution: QA Oversight personnel are responsible for planning and conducting audits of clinical trial sites, investigator sites, vendors, and other relevant entities involved in the conduct of clinical trials. These audits aim to evaluate compliance with protocols, regulatory requirements, and SOPs.
• Risk Assessment and Management: QA Oversight professionals conduct risk assessments to identify potential risks and areas of non-compliance within clinical trial processes. They develop risk mitigation strategies and monitor their implementation to ensure effective risk management throughout the trial.
• Documentation Review: QA Oversight involves reviewing essential trial documentation, including study protocols, informed consent forms, case report forms, and regulatory submissions, to ensure accuracy, completeness, and compliance with regulatory requirements.
• Training and Education: QA Oversight personnel provide training and education to clinical trial staff on GCP principles, regulatory requirements, and SOPs. This helps to ensure that all personnel involved in the conduct of clinical trials are knowledgeable about their responsibilities and compliant with relevant regulations.
• Quality Management System (QMS) Implementation: QA Oversight professionals contribute to the development, implementation, and maintenance of a robust QMS within the organization conducting clinical trials. This includes establishing procedures for document control, deviation management, corrective and preventive actions (CAPAs), and continuous improvement.
• Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity.
• Investigational Product Oversight: QA Oversight personnel ensure proper handling, storage, dispensing, and accountability of investigational products (IPs) throughout the trial. This involves verifying compliance with IP-related regulations and ensuring that IPs are used in accordance with the approved protocol.
• Vendor Oversight: In cases where vendors are involved in the conduct of clinical trials (e.g., central laboratories, contract research organizations), QA Oversight personnel oversee vendor activities to ensure compliance with contractual agreements, SOPs, and regulatory requirements.
• Reporting and Communication: QA Oversight professionals communicate audit findings, compliance issues, and corrective actions to relevant stakeholders, including clinical trial sponsors, investigators, and regulatory authorities. They also generate periodic reports on QA activities and compliance metrics.
• Continuous Improvement: QA Oversight involves ongoing evaluation and improvement of quality systems, processes, and procedures to enhance the overall quality and compliance of clinical trial conduct. This includes conducting root cause analyses of compliance issues and implementing corrective and preventive actions to prevent recurrence.
• Stay Updated with Regulations: They stay abreast of updates to relevant regulations, guidelines, and industry best practices to ensure ongoing compliance and adaptation of quality assurance processes

• Overall, the QA Oversight role plays a critical role in safeguarding the rights, safety, and well-being of clinical trial participants, as well as ensuring the integrity and reliability of clinical trial data.

Desired Characteristics:

• Previous Quality Assurance 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