Senior Director, Clinical PV Quality (Remote)

at  Jazz Pharmaceuticals

IF YOU ARE A CURRENT JAZZ EMPLOYEE PLEASE APPLY VIA THE INTERNAL CAREER SITE.

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.

BRIEF DESCRIPTION:

To lead the Clinical and Pharmacovigilance Quality Assurance (CPVQA) function in ensuring that all aspects of the global Jazz clinical and pharmacovigilance business meets regulatory quality and GXP compliance expectations.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

Knowledge:

• Thorough understanding of national and international guidance and regulations that impact clinical trials and the safety and welfare of participants and patients receiving Jazz products

Experience:

• Substantial and relevant experience (typically 16+ years) in the pharmaceutical or biotechnology industry.
• Substantial and relevant experience (typically a minimum of 7 years) in Quality leadership roles, including experience in GCP/GPvP & cGLP

Skills:

• Working knowledge of office IT packages
• Working knowledge of eQMS
• Very high level of written and verbal communication skills

REQUIRED/PREFERRED EDUCATION AND LICENSES

• Minimum of a Bachelors degree required in a science discipline or other relevant field.
• Post-graduate (Masters/PhD) preferred
  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.
  The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html

• To ensure the implementation of the global Quality strategy, as relevant to GcP/GPvP across the clinical development business.
• To build collaborative relationships with key internal and external stakeholders.
• To lead and develop the CQA group resources and build an organization which has the right structure and people capabilities to realise the vision.
• As part of the Global Quality Leadership team (GQLT), contribute to the setting of long-term goals and priorities to ensure the business achieves and maintains the company’s Quality strategy.
• To influence senior leadership in support of Quality intent and strategy.
• To develop and initiate efforts designed to constantly improve and globally harmonise clinical development (including Pharmacovigilance) processes and systems.
• To ensure preparedness for inspections, identification of compliance vulnerabilities and to develop responses for inspectional observations.
• To interpret, communicate and implement changes in GCP/GPvP and compliance related regulations, standards and practices.
• Act as an ambassador to protect the rights and well-being of all subjects participating in drug development activities on behalf of the Company.
• To verify that data integrity principles are adhered to within clinical development and pharmacovigilance activities.
• Strategically assesses and reports to the Vice President, Quality and Corporate Senior Management, the risk of any critical or major audit finding identified at any study specific, Vendor, Marketing Partner or internal process/system audit.
• Promotes quality by design awareness amongst company personnel and develop and maintain company GCP, cGLP, GLP GPvP and other quality standards by means of training, review, advice and guidance services.
• Collaborates with other global departments to develop audit programs to support clinical trials, pharmacovigilance and internal activities and ensures the smooth running of assigned programmes during their lifetime
• Manages and supports activities for Company and Clinical Investigator inspections/external audits (GCP & GPvP) conducted by national and international regulatory authorities (RA) and other external bodies such as marketing partners by acting as Inspection Lead/Host