Director, Quality Assurance
Quality | San Carlos, CA | Full Time
ChemoCentryx is searching for a Director, Quality Assurance to lead, develop, implement and maintain a robust and compliant Quality Management Systems (QMS) at ChemoCentryx, Inc. (CCXI) to manage CCXI clinical and commercial product assets in accordance with the global regulatory requirements. This Director will report to the Vice President of Quality and work out our Mountain View offices and then starting in April out of our brand new state-of-the-art corporate center in San Carlos, CA.
The Director will be responsible for developing Quality Systems, processes, procedures, and quality standards, in collaboration with his/her immediate manager, and other CCXI stake holders (Product Development, Manufacturing and Supply Chain, and Clinical Operations) to establish a risk-based QMS.
The Director is directly responsible for managing QA responsibilities for CCXI products through all phases of product development, clinical, commercial and life-cycle. They will directly oversee or manage through direct reports, QA responsibilities; Document Control, Deviations, CAPA, Change Control, Specifications, SOPs, Product Complaints, Audits, Batch Record Review, Lot Release and Validation. The Director will have direct responsibility for managing all GMP activities at CCXI.
Essential Duties and Responsibilities include:
- Provide strategic leadership and implement a robust Quality Management Systems.
- Develop, implement and maintain a compliant Quality Management System for managing CCXI products (clinical and commercial) in accordance with US and global regulatory requirements including standards, and guidance.
- Oversee and manage all aspects of Quality Assurance functions; Batch Record Review, Lot Release, Quality Systems (Deviations, CAPA, Change Control, OOS, Product Complaints, Internal/External Audits and Risk Management), and Validation activities.
- Review and approve Master Batch Records (and executed batch records), Specifications, GxP Quality Incidents, Investigations, Protocols, Reports, SOP, Change Control, Deviations, CAPA with attention to detail and compliance to regulations and guidances.
- Maintain supplier vigilance through key process and product quality metrics to assure the quality of materials/services including compliance to specifications and regulations.
- Maintain GxP controlled documents, vendor files and conduct periodic assessment to ensure compliance with current regulations and standards.
- Schedule and conduct periodic Management Review, including tracking, trending all KPIs (quality metrics) and design effective action plans to address adverse trends.
- Identify, assess and communicate QA strategies, KPI metrics, gaps and compliance risks to the manager and senior management on an as needed basis.
- Partner with Technical Operations (Manufacturing, Supply Chain, Product/Analytical Development) and other functions (RA, CO & PM) to drive corporate objectives, product assets and ensure compliance with global quality, regulatory and compliance requirements.
- Act as the Quality SME representing Quality during regulatory audits i.e., State and US FDA, EU, including partner audits.
- Act as the Quality Team Lead in supporting CCX commercial product launch, for all applicable territories.
- Collaborate and support GCP Quality and Supplier Quality to conduct external audits, management of CxO’s, and assure that Quality Agreements are in place and current for all major CxO’s.
- Develop a high performing team to manage GMP Quality responsibilities. Hold the team accountable for preparing and achievable tactical goals.
- Prepare accurate budget and headcount forecasts for Quality and oversee the organization within the allotted budget and headcount.
- Provide training, development, and growth opportunities for employees.
- Manage other QA responsibilities to support GxP functions, as assigned by the manager.
- Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
- 15+ years’ in the pharmaceutical life sciences industry with extensive knowledge and experience managing Quality Systems and Quality Operations responsibilities, with 10+ years in Quality Management roles managing commercial products in a pharmaceutical industry.
- Experience managing commercial products, implementing Quality Systems, and working with external GxP service provider is preferred.
- Strong leadership capabilities, interpersonal, communication, and influencing skills.
- Strong working knowledge of GxP US and global regulations (21 CFR Part 312, 314, 210, 211, 11, ICH Quality Standards, EU GMP Directives and Annexes).
- Experience with implementation and use of electronic systems; Trackwise, Veeva, LMS, Tracelink, ERP etc.
- Proven track record and experience in managing quality systems and processes for commercial products.
- Proactive in identifying opportunities along with strong troubleshooting, problem solving and negotiation skills.
- Hands on execution on all aspects of quality assurance functions working in an entrepreneurial and fast paced environment.
- Experienced and/or certified quality auditor with proven track record in negotiating quality agreements, hosting audits and conducting various types of vendor audits (i.e., raw material suppliers, CxO’s and service providers).
- Leads by example, collaborative and can work in a cross-functional team.
- Working knowledge of ICH Standards and risk management tools, Failure Mode Effects Analysis (FMEA), and/or lean six sigma concepts.
- 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 %)
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.
At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry. All our employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts. ChemoCentryx employees enjoy a comprehensive benefits package including medical, dental and vision coverage as well as life insurance, and short and long-term disability insurance.