Director, Clinical Quality Assurance

Jazz Pharmaceutical; Penn (Westmoreland County); On-site; USD 184,000 - 276,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a Director of Clinical Quality Assurance to ensure GCP compliance across clinical development, aligned with global quality strategy and regulatory requirements. You will lead the CQA team, manage CROs, and drive inspections readiness while fostering a culture of quality and continuous improvement.

The ideal candidate has 14+ years in pharma/biotech, strong audit and risk management expertise, and excellent communication skills.

Qualifications

• Typically, 14+ years relevant work experience in the Pharmaceutical or Biotechnology industry.
• Thorough understanding and application of GCP regulations and guidelines.
• Experience in audit principles, procedures and techniques.
• Deep understanding of risk management in clinical trials and CQA activities.

Responsibilities

• Supports implementation of the global quality strategy for GCP across clinical development.
• Provides strategic GCP compliance support to therapeutic areas and study teams.
• Leads CRO and vendor compliance oversight and issue management.
• Drives inspection readiness and continuous process improvement.
• Promotes a culture of quality, collaboration, and operational excellence.

Skills

eQMS

eTMF

Written and verbal communication

Organisational skills

Attention to detail

Learning and self-improvement

Education

Bachelor's degree in science

Post-graduate degree preferred

Tools

eQMS

Job description

If you are a current Jazz employee please apply via the Internal Career site

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. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job 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.

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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Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is:

$184,000.00 - $276,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html