Director, Clinical Quality Assurance

The Director of Clinical Quality Assurance is responsible for ensuring clinical research activities are conducted as per ICH GCP, relevant international and local regulations, requirements, guidelines, and Jazz written standards.

To lead and manage key strategic objectives for the CQA team, in alignment with the global quality strategy. To champion and increase the CQA footprint within the organization. Manage key business relationships with both internal and external stakeholders.

An experienced and detail-oriented Leader who utilizes a risk-based strategy to prioritize quality activities. This role collaborates closely with the cross-functional Groups to lead issue identification and escalation, drive trial and vendor performance oversight, guide the development and execution of action plans, and drive inspection readiness and process improvement.

Essential Functions/Responsibilities

• Supports the implementation of the global quality strategy, as relevant to GcP across the clinical development business.

• Builds collaborative relationships with key internal and external stakeholders.

• Leads activities that support the implementation of the global quality management system.

• Supports the development of Quality and CQA team goals, objectives, and initiatives.

• Provides strategic and technical GCP compliance support to Jazz therapeutic area and clinical study teams.

• Drive knowledge-sharing and promote learning of GCP regulations and best practices across the organisation.

• Manage CQA programs and ensure clinical studies are conducted in accordance with regulations, guidelines, and Jazz procedures and standards.

• Provide oversight of Contract Research Organization (CRO) and vendor compliance, including compliance/quality issue management.

• Collaborate closely with Clinical Compliance and other functional teams to identify risks, implement mitigations, resolve issues, and drive process improvement.

• Support QMS metrics reporting and tracking.

• Lead and manage regulatory inspection readiness activities and supporting the inspections in the front room/backroom as required.

• Promote a quality, compliance, and operational excellence culture, fostering collaboration, continuous improvement, and effective team communication.

• Completes or delegates for-cause audits and Investigations.

• Prioritises workload in alignment of the corporate objectives.

• Acts as an ambassador to protect the rights and wellbeing of all participants in drug development activities on behalf of the company.

• To have an in depth understanding and be able to apply appropriate guidelines and regulations in a risk-based manner, including ICH, FDA, MHRA and EMA, relating to Clinical Trials, for more complex situations.

• Resolve a wide range of issues in creative, pragmatic, and compliant ways. Apply in-depth knowledge of broader departmental objectives to analyse and solve issues.

• Provide support to business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and regulated drug development activities.

Required Knowledge, Skills, and Abilities

• Typically, 14+ years relevant work experience in the Pharmaceutical or Biotechnology industry

• Established Clinical Quality Professional, demonstrable CQA compliance experience and thorough understanding and application of GCP regulations, applicable country regulations ad guidelines.

• Demonstratable knowledge and experience in audit principles, procedures and techniques

• Deep understanding of risk management in clinical trials and the ability to apply a risk-based approach to both clinical studies and CQA activities.

Skills:

• Working knowledge of office IT packages including eQMS, eTMF

• High level of written and verbal communication skills

• Good organisational skills, with the ability to multi-task, capability to prioritise multiple tasks and meet deadlines. including the ability to work independently or as part of a team.

• Positive thinking and excellent attention to detail

• Actively committed to self-improvement, learning, and applying new knowledge to improve team performance and outcomes.

Attributes and Behaviours:

• Proven organisational and interpersonal skills.

• Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner.

• Has a high level of functional and technical knowledge and skills.

• Is personally committed and actively works to continuously improve him/herself; understands that different situation and levels may call for different skills and approaches; works to deploy strengths; works on compensating for weakness and limits.

Required/Preferred Education and Licenses:

• Bachelor's degree in science or related discipline

• Post-graduate (Masters/PhD) preferred.

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