Director, Clinical Quality Assurance

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

About the role

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. This role leads and manages key strategic objectives for the CQA team, in alignment with the global quality strategy, and champions the CQA footprint within the organization. The position manages key business relationships with both internal and external stakeholders and collaborates closely with cross-functional groups to drive issue identification, escalation, trial and vendor performance oversight, inspection readiness, and process improvement.

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.
• Drives knowledge-sharing and promotes learning of GCP regulations and best practices across the organization.
• Manages CQA programs and ensures clinical studies are conducted in accordance with regulations, guidelines, and Jazz procedures and standards.
• Provides oversight of Contract Research Organization (CRO) and vendor compliance, including compliance/quality issue management.
• Collaborates closely with Clinical Compliance and other functional teams to identify risks, implement mitigations, resolve issues, and drive process improvement.
• Supports QMS metrics reporting and tracking.
• Leads and manages regulatory inspection readiness activities and supports inspections in the front room/backroom as required.
• Promotes a quality, compliance, and operational excellence culture, fostering collaboration, continuous improvement, and effective team communication.
• Completes or delegates for-cause audits and investigations.
• Prioritizes workload in alignment with corporate objectives.
• Acts as an ambassador to protect the rights and wellbeing of all participants in drug development activities on behalf of the company.
• Applies in-depth understanding of guidelines and regulations (ICH, FDA, MHRA, EMA) in a risk-based manner for complex clinical trial situations.
• Resolves a wide range of issues in creative, pragmatic, and compliant ways.
• Provides support to business initiatives involving systems, processes, procedures, regulations, and tools for clinical trial conduct and regulated drug development activities.

Requirements

• Typically, 14+ years relevant work experience in the Pharmaceutical or Biotechnology industry.
• Established Clinical Quality Professional with demonstrable CQA compliance experience and thorough understanding and application of GCP regulations, applicable country regulations, and guidelines.
• Demonstrable 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 organizational skills, with the ability to multi-task, prioritize multiple tasks, and meet deadlines.
• 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 organizational and interpersonal skills.
• Is widely trusted; presents the unvarnished truth in an appropriate and helpful manner.
• Has a high level of functional and technical knowledge and skills.
• Personally committed and actively works to continuously improve; understands different situations and levels may call for different skills and approaches.

Qualifications

• Bachelor’s degree in science or related discipline.
• Post-graduate (Masters/PhD) preferred.

Pay

For US-based candidates, the full and complete base pay range is $184,000.00 - $276,000.00. Individual compensation paid within this range will depend on qualifications, skills, relevant experience, job knowledge, and other pertinent factors. This range will be reviewed on a regular basis.

The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

Benefits

• Medical, dental, and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.

For more information on benefits, visit Jazz Pharmaceuticals Benefits.