No H1B and/or C2C please!!

Required Industry Experience: Pharma/Biotech

Job Title: Associate Director (Business Partner - R&D Quality)

W2 Contract & Hybrid role

Work Location: Foster City, CA

One of our leading Pharmaceutical client is looking for an Associate Director (Business Partner - R&D Quality), act as a R&D Quality Business Partner to client’s R&D functions or vendors supporting Client R&D. will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Clinical Practices (GCP).

Required 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.
• 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.

Responsibilities:

• You will educate assigned groups on Client quality policy and procedural standards, GCP regulations and other requirements.
• Responsible for providing expert advice on GCP risk minimization and mitigation.
• Helping the business understand potential impacts of risk and alternatives to best address risk.
• You will participate in Quality forums, cross-functional teams and/or projects.
• Act as the central point of contact for QMS-related communications to assigned groups.
• Collaborate with other R&D Quality groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support.

If you are a right fit then please apply quick!!