LeadStack Inc. is an award-winning, one of the nation’s fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we’re proud to partner with some of the most admired Fortune 500 brands in the world.

Job: Associate Director

Location: Foster City, CA

Duration: 8 Months

Pay Range: $120/hr - $135/hr on W2

Job Title: Associate Director, Clinical Quality Business Partners, Laboratory Compliance, R&D Quality & Medical Governance

Summary:

· We are looking for an expert Quality Assurance Professional with experience advising research and development teams in Good Clinical Laboratory Practices (GCLP) quality strategy within a pharmaceutical organization. As a member of the Clinical Quality Operations Excellence team, you will provide leadership provide GCLP subject matter expertise within R&D Quality & Medical Governance, and key functional research and development leaders.

· This role is suited to candidates who possess strong communication, leadership, and strategic risk-based thinking skills. Utilizing expert GCLP knowledge in this role you will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization.

Qualifications

· BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS)

· Significant experience working to or advising business on GCLP quality strategy

· Understand the use and application of bioanalytical and biomarker assays in clinical trials

· Experience in GCP regulations and guidance, such as ICH E6 R2

· Working knowledge of IVD regulations, such as IVDR and IVD quality strategy is a plus

· GLP experience is a plus

· Understanding of FDA + Global regulations and Guidance for GLP/ GCLP, and how to apply them

· Must have experience advising business in a compliance related role

· Recognized as an expert resource on a range of lab compliance topics

· Bio-pharma sponsor experience preferred

· Is a strategic problem solver with a deep understanding of drug development

· Exceptional verbal, written, interpersonal skills to include delivering presentations to senior leaders of the organization

· Experience with CAPA management programs preferred

To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (425)400-1050 or email at sahil.sharma@leadstackinc.com

Job Type: Contract

Salary: $120.00 - $135.00 per hour

Schedule:

• 8 hour shift

Work Location: One location

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