Senior Manager, Quality
Job Details
- Req ID:
- R009737
- Location:
- California -- [Remote/Home-Based]
- Category:
- Technical Operations
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:
The position will provide quality support to the Jazz (Affiliate) North America organization, providing quality management oversight for product supply, primarily distribution via Channel Operations but also providing quality support capability for other the US-based manufacturing/distribution operations of Jazz drug products. This role also supports the US state licensing program via our approved vendor.
Essential Functions/Responsibilities
- Oversee the State Licenses program and ensure current data is provided by Jazz Inc
- Maintain the state licensing vendor relationship and management of invoices
- Provide quality oversight of temperature-controlled shipments, and quality decision on any temperature excursions during transit or storage.
- Review/approve of Jazz standard operating procedures, policies and all related documentation to support US based cGMP procedures & practices and the Drug Supply Chain Security Act (DSCSA).
- Support Channel Operations for all distribution-related quality matters
- Review of quality documentation including change controls, deviations, complaints, validation documentation, SOPs and specifications relating to US distribution activities.
- Provide quality decision and disposition changes for returned, rejected, recalled or falsified products at US distribution partners.
- Escalate critical quality issues related to US distribution activities, including product recall
- Act as the US representative to the FDA for Jazz foreign manufacturing establishments.
- Vendor management to ensure compliance with FDA regulatory requirements, including the creation/periodic update of Quality Technical Agreements and/or Service Agreements
- Provide US data for Quality Management Review meetings.
- Ensure US FDA and home state inspection/audit readiness for US commercial operations.
- Participate in the Jazz global self-inspection programme; perform self-inspections as required.
Required Knowledge, Skills, and Abilities
- Sound awareness and understanding of pharmaceutical business, especially with regard to quality, supply chain and regulatory requirements such as state licensing.
- Knowledge of Good Manufacturing Practices (GMP), 21 CFR 210/211, DSCSA and ICH Guidelines.
- Strong verbal and written communication skills and presentation ability to various audience levels
Required/Preferred Education and Licenses
- Bachelor's degree in chemistry, biology or a related Life Sciences discipline.
- Minimum 10 years in international pharmaceutical and/or biotech industry with increased level of responsibility
- Ability to operate efficiently in a complex matrix organization and global environment
- Experience in managing external contractors
- Lead auditor training and experience
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: $124,000.00 - $186,000.00
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.