Manager, Supplier Quality
Quality | San Carlos, CA | Full Time
ChemoCentryx is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
As a clinical-stage company with a broad portfolio in multiple therapeutic areas, ChemoCentryx pushes beyond “good enough” and strives for a totally new way of healing.
The Manager, Supplier Quality will lead and implement a robust and compliant Supplier Quality Management (SQM) program at ChemoCentryx (CCX) to manage CxO’s in accordance with the global pharmaceutical regulatory requirements. The incumbent will be responsible for developing processes, procedures, and quality standards, in collaboration with his/her immediate manager, and other stake holders (Product Development, Manufacturing and Supply Chain, Clinical Operations, and QA) to establish a risk-based SQM program. This position will report to the VP, Quality and serve as the key subject matter expert (SME) for CCX including representing the SQM to regulators during agency and partner audits.
Essential Duties and Responsibilities:
- Implement a complaint SQM program, systems and procedures to manage CCX GxP vendors, CxO’s and service providers including quality/compliance oversight and conducting audits.
- Draft new and/or enhance existing SOPs for supplier selection, qualification and management of all external CCX vendors; contract manufacturing organizations (CMO’s), contract research organizations (CRO’s) and service providers (i.e., test laboratories, GCP Vendors and service providers).
- Develop an annual external supplier audit schedule, generate audit plans and conduct routine quality audits of GMP suppliers, CMO’s, and service providers.
- Negotiate and draft commercial quality technical agreements with all critical suppliers, CMO’s and service providers.
- Manage product quality complaints, quality events, incidents and CAPAs associated with Product(s) and/or services provided by the suppliers and initiate Supplier Corrective Actions (SCAR’s) to manage supplier quality incidents.
- Maintain an Approved GxP Vendor list for all CCX Vendors.
- Participate in the Specification Review Board Committee to review and approve internal and external Material Specifications.
- Maintain supplier vigilance through key process and product quality metrics (KPI) to assure the quality of materials/services provided and compliance with specifications and regulations.
- Maintain GxP vendor files and conduct periodic assessment to ensure all vendor certification documents, licenses, and statements are current and comply with current regulations and standards.
- Maintain vendor audit reports, audit responses, and pertinent corrective actions, follow-up for audits conducted in support of the supplier qualification program.
- Track and trend key quality metrics related to supplier audits, product performance and quality events (i.e., incidents, change control, closure of quality incidents and complaints).
- Periodically report all metrics including significant quality incidents to senior management.
- Conduct periodic risk assessments to support of the supplier qualification program, quality, compliance and inspection status.
- SME for supplier quality management program including presenting the program to regulatory agencies during inspections.
- Manage other QA responsibilities to support GxP functions, as assigned by the manager.
- A minimum, Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
- A minimum of 8-10 years’ in the pharmaceutical Life Sciences industry with extensive knowledge and experience managing quality assurance, auditing processes and at least 5 years’ managing responsibilities in Quality Assurance in a pharmaceutical industry.
- Experienced and/or certified quality auditor with proven track record in negotiating quality agreements, hosting internal audits and conducting various types of supplier and vendor audits (i.e., raw material suppliers, CxO’s and service providers etc.).
- Strong working knowledge of GxP US and global regulations (21 CFR Part 210, 211, ICH Q7, Q9, Q10 , EU GMP Directives and Annexes) is required.
- Proven track record and experience in managing supplier quality, systems and processes.
- Proactive in identifying opportunities along with strong problem solving and negotiation skills.
- Hands on execution on all aspects of supplier quality functions working in an entrepreneurial and fast paced environment.
- Strong leadership capabilities, interpersonal, communication, and influencing skills required.
- Leads by example and highly collaborative and can work in a cross-functional team.
- Strong verbal, written communication skills and computer skills (Microsoft Excel, Word, Visio, MS Project and PowerPoint) are required.
- Must be able to travel (minimum 25 %)