Quality Director (R&D) - Pharma/Biotech - Hybrid!!

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 requirement s, 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!!

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