Associate Director
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Job Description
Job Title: Associate Director (contractor) Functional Quality Business Partner R&D Quality
Contract Details: 12 months; Hybrid with core onsite days TuesdayThursday
Location: Foster City CA
POSITION OVERVIEW:
You will act as the R&D Quality Business Partner to assigned groups such as Client R&D functions or vendors supporting Client R&D. You will provide strategic expert advice and consultation on R&D quality risk and continuous improvement with impact across crossfunctional Good Clinical Practices (GCP). You will educate assigned groups on Client quality policy and procedural standards GCP regulations and other requirements. You will provide expert advice on GCP risk minimization and mitigation. You will help the business understand potential impacts of risk and alternatives to best address risk. You will also provide leadership support in escalating quality risks or issues. You will participate in Quality forums crossfunctional teams and/or projects. You will act as the central point of contact for QMSrelated communications to assigned groups; consolidating and channeling justintime information and resources to assist assigned groups. You will collaborate with other R&D Quality groups to ensure justintime support and resources to assigned groups including data reporting training audit inspection risk assessment and deviation/ CAPA management support. You may support Client during regulatory inspections.
EXAMPLE RESPONSIBILITIES:
REQUIREMENTS:
Education & Experience
- PharmD/PhD with 2 years experience.
- MA/MS/MBA with 8 years relevant experience.
- BA/BS with 10 years relevant experience.
- Significant experience advising business functions in the biopharma industry on GCP quality and compliance requirements evolving regulations risk minimization and mitigation and continuous improvement.
- Previous GCP quality experience at a Sponsor or CRO; Previous experience as an auditor highly desired.
- Experience working across a broad spectrum of quality and/or compliance activities including authoring and reviewing SOPs conducting internal auditing supporting regulatory inspections developing and managing CAPAs and deviations and training others on quality and/or compliance requirements.
- Significant experience participating in crossfunctional projects and teams with responsibilities related to clinical trials or other drug development activities.
- Experience working with total quality management methodologies such as Lean Six Sigma is a plus.
Knowledge & Other Requirements
- Thorough knowledge of standards systems policies and procedures that enable Good Clinical Practices (GCP) QMS operations and compliance within the biopharma industry. Experience with Good Clinical Laboratory Practices (GCLP) Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC) is a plus.
- Thorough knowledge of the drug development process including all key functions involved in the various stages of drug development from early research through postmarketing.
- Demonstrates advanced business knowledge and analytical skills as evidenced by strengths in assessing complex systems and data and understanding the quality and compliance implications.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills.
- Strong negotiation and conflict resolution skills.
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Employment Type
Full Time
