[Hiring] Director, Clinical Quality Assurance @Jazz Pharmaceuticals

Role Description

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.

• Lead and manage key strategic objectives for the CQA team, in alignment with the global quality strategy.
• Champion and increase the CQA footprint within the organization.
• Manage key business relationships with both internal and external stakeholders.
• Utilize a risk-based strategy to prioritize quality activities.
• Collaborate closely with cross-functional Groups to lead issue identification and escalation.
• Drive trial and vendor performance oversight.
• Guide the development and execution of action plans.
• Drive inspection readiness and process improvement.

Qualifications

• Typically, 14+ years relevant work experience in the Pharmaceutical or Biotechnology industry.
• Established Clinical Quality Professional with demonstrable CQA compliance experience.
• Thorough understanding and application of GCP regulations, applicable country regulations, and guidelines.
• Demonstratable knowledge and experience in audit principles, procedures, and techniques.
• Deep understanding of risk management in clinical trials.

Requirements

• 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 and prioritize tasks.
• Positive thinking and excellent attention to detail.
• Actively committed to self-improvement and learning.

Benefits

• Medical, dental, and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.
• Discretionary annual cash bonus or incentive compensation.
• Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.

Company Description

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases. The company has a diverse portfolio of marketed medicines, including therapies for sleep disorders, epilepsy, and cancer treatments. Jazz is headquartered in Dublin, Ireland, with research and development laboratories and manufacturing facilities in multiple countries.