Associate Director, Clinical Compliance
Company: Jazz Pharmaceuticals
Posted on: November 23, 2021
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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. This
position provides GCP/GLP compliance support to Jazz therapeutic
area and clinical study teams. The key activity of the role is
providing expertise and guidance regarding regulatory requirements,
GCP/GLP guidelines and Jazz Standard Operating Procedures (SOPs)
for the conduct of Early Development work and clinical studies.The
position will utilize a risk-based strategy to prioritize
compliance support for regulated activities, identify and escalate
compliance issues, enable decision-making, and support the
development and execution of effective and comprehensive action
plans to address quality and compliance risks. The Associate
Director, Clinical Compliance serves as an important conduit to the
broader organization to ensure a culture of quality and
compliance.Essential Job Functions:
- Provide quality leadership and direction to Jazz R&D staff
on GCP/GLP related activities/issues and act as GCP/GLP
expert/consultant for R&D colleagues.
- Act as Clinical Compliance member of clinical study teams for
relevant Therapeutic Areas and provide quality oversight of Early
Development activities with a focus on vendor management.
- Collaborate with stakeholders in conducting ongoing risk
assessment of clinical trial activity in order to identify priority
studies, compliance metrics for tracking, high-risk vendors, and
key compliance activities (i.e. protocol review, vendor
evaluations, inspection readiness).
- Identify and escalate significant quality and compliance issues
to the relevant leadership, including supporting assessment of
- Participate as member of Contract Research Organization
(CRO)/Vendor governance teams for assigned Therapeutic
- Establish relationship with CRO Quality Team member for the
ongoing review of quality and compliance issues.
- Participate in vendor evaluations as a Subject Matter Expert
(SME) as needed.
- Support clinical teams/functions in drafting responses and
CAPAs to internal and external audit findings.
- Provide support and guidance for Jazz Quality Management System
activities including self-reporting deviations, root cause analysis
and CAPA plan development and evaluation.
- Identify and anticipate trends in quality issues and
collaborate with functional management to ensure risk-managed
solutions are implemented in a timely fashion.
- Maintain high level of expertise in international GCP/GLP
regulations and internal Policies and Procedure that may impact
- Provide support and guidance during and following internal
audits and external regulatory inspections (as required)
- Provide expertise and consultative guidance on business
initiatives involving systems, processes, procedures, regulations
and tools intended for use in clinical trial conduct and/or
regulated drug development activities
- Lead / manage inspection readiness activities and ensure
project teams are trained and prepared for regulatory
- Minimum of 10 years of academic, pharmaceutical or
biotechnology industry experience, with at least 5 years in a
quality assurance/regulatory compliance position.
- Thorough knowledge and understanding of drug development and
the clinical trial process.
- In-depth knowledge of current regulatory and ICH GCP
requirements and experience with international regulations,
guidelines and standards is required. Working knowledge of GLP
requirements is a plus.Education
- Bachelor s Degree in Business or Life sciences is
- Excellent written and verbal communications skills with the
ability to influence others and gain commitment.
- Ability to work in an entrepreneurial and fast paced
- Must be disciplined, detail oriented and able to multitask and
work efficiently and independently.
- Ability to collaborate and partner with various internal
- Ability to work in a team environment.
- Highly developed problem solving skills and the ability to
resolve difficult conflicts.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.
Associated topics: biomedical, drug, drug discovery, food
scientist, health, kinesiology, medical, medicine, pharmacy,
Keywords: Jazz Pharmaceuticals, Philadelphia , Associate Director, Clinical Compliance, Executive , Philadelphia, Pennsylvania
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