Director, Vendor and Partners Quality Management jobs in United States
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Rigel Pharmaceuticals Inc. · 1 day ago

Director, Vendor and Partners Quality Management

Rigel Pharmaceuticals Inc. is seeking a Director of Vendors and Partners Quality Management to oversee the external quality network with global commercial partners and GxP vendors. This role includes managing quality agreements, conducting audits, and ensuring compliance with regulatory requirements.

BiotechnologyHealth CarePharmaceuticalTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Establish, maintain, and manage Quality Agreements with partners and vendors to ensure clear GxP responsibilities
Lead the vendor quality management program through select-implement-manage-decommission lifecycle across GMP, GCP, and GLP areas
Manage partner complaint investigations and ensure compliant communication and documentation closure
Oversee vendor and partner audits, including scheduling, conduct, reporting, and follow-up actions
Coordinate exchange of quality documents with partners to support regulatory submissions and inspections
Lead Rigel Change Management program for clinical and commercial products , applying phase-appropriate and risk-based framework and ensuring compliance with regulatory requirements
Serve as a Quality lead for Rigel Technology Transfer projects
Provide Quality support for assessment and implementation of new assets
Develop and maintain metrics (KPIs) to monitor vendor and partner quality performance
Collaborate with Regulatory, Legal, and Supply Chain to ensure partners and vendors meet contractual and regulatory obligations
Provide QA input into business development and alliance management processes
Stay current with global regulatory expectations impacting partner and vendor oversight programs
Represent Rigel Quality in governance meetings with external partners and key suppliers

Qualification

GxP regulationsVendor managementQuality AssuranceAudit managementQuality AgreementsInterpersonal skillsCollaboration

Required

Bachelor's degree in life sciences or related discipline
12+ years of pharmaceutical Quality Assurance experience, including vendor and partner management
Strong understanding of global GxP regulations and supplier quality requirements
Experience leading audits and managing external Quality Agreements
Knowledge of both commercial and clinical product quality systems and regulatory submissions
Exceptional interpersonal skills for effective collaboration with external partners and cross-functional stakeholders
Ability to travel domestically and internationally for audits and partner meetings

Preferred

advanced degree preferred

Company

Rigel Pharmaceuticals Inc.

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Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders and cancer.

H1B Sponsorship

Rigel Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$192.5M
Key Investors
U.S. Department of DefenseMPM Capital
2021-01-29Grant· $16.5M
2011-05-27Post Ipo Equity· $130M
2010-01-01Post Ipo Equity

Leadership Team

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Raul R. Rodriguez
President and CEO
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Dean Schorno
CFO
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Company data provided by crunchbase