Director, Vendor and Partners Quality Management
Scorpion Therapeutics, South San Francisco, California, us, 94083
Role Summary
The Director, Vendors and Partners Quality Management provides strategic and operational oversight of Rigel’s external quality network, including global commercial partners and GxP vendors. This role ensures quality and compliance alignment with partners who hold Marketing Authorizations for Rigel’s products outside the USA and drives quality and compliance with Rigel vendors supplying GxP materials or services. The Director manages quality agreements, partner and vendor audits, and the exchange of quality documentation to support regulatory filings and inspections. 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. Qualifications
Bachelor’s degree in life sciences or related discipline; advanced degree preferred. 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. Additional Requirements
PHYSICAL DEMANDS: Ability to stand, walk, sit, talk, and hear; vision requirements as necessary for work tasks. WORK ENVIRONMENT: Moderate noise level; some travel may be required.
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The Director, Vendors and Partners Quality Management provides strategic and operational oversight of Rigel’s external quality network, including global commercial partners and GxP vendors. This role ensures quality and compliance alignment with partners who hold Marketing Authorizations for Rigel’s products outside the USA and drives quality and compliance with Rigel vendors supplying GxP materials or services. The Director manages quality agreements, partner and vendor audits, and the exchange of quality documentation to support regulatory filings and inspections. 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. Qualifications
Bachelor’s degree in life sciences or related discipline; advanced degree preferred. 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. Additional Requirements
PHYSICAL DEMANDS: Ability to stand, walk, sit, talk, and hear; vision requirements as necessary for work tasks. WORK ENVIRONMENT: Moderate noise level; some travel may be required.
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