Associate Director, Supplier Quality Management (IVD/Medical Device)

Menlo Park, CA, United States
Feb 14, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit

We are seeking a highly motivated hands-on leader to join us as an Associate Director, Supplier Quality Management (SQM) for contract manufacturing organizations (CMOs), contract test labs (CTLs), third party logistics (3PLs) (couriers, remote warehousing) and Equipment service providers (e.g. calibration, cleaning). You will lead within the Quality team to support our efforts of improving GRAIL's Quality Management Systems. This individual will drive cross-functionally to execute and further define the SQM program.

You Will:

• Manage cross-functionally (Supply Chain, Process Engineering, Manufacturing, Regulatory Affairs, Clinical laboratory operations, Clinical compliance operations) within GRAIL and externally to assure compliance and excellent relationships with the CMOs, CTLs, 3PLs and service providers.
• Accountable for the supplier compliance of: Audits, Supplier Quality Agreements (SQA), SCARs, supplier Questionnaires, Supplier Request for Information (RFI), and management of supplier initiated changes to include; (Supplier qualification and specification development processes that use risk-based tools for qualification, classification and performance monitoring; Quality Agreements to assure key quality expectations are reflected in the supplier's operations and updates for changes are managed and distributed to key impacted operations; Supplier initiated change notifications; Phase-in appropriate supplier qualification requirements)
• Conduct supplier audits activities to include: (Develop an audit plan, prepare audit reports, communicate findings, audit responses, compliance assessment including assessment of compliance risk to support Supply Chain, Manufacturing, Material Management; Accountable that the audit schedule and approved supplier list are maintained and up-to-date.)
• Monitor and report on meaningful SQM performance metrics as well as Supplier performance metrics.
• Provide leadership and direction for CMO, lab-related or service provider issues - SCARs, CAPAs, OOS, deviations and change records.
• Collaborate with a cross-functional team to improve processes/share responsibilities to include leading a Supplier Review Board.
• Participate as a representative of SQM for internal project teams as well as joint committee meetings with suppliers, Material Review Committee, and ERP implementation team.
• Assure all SQM related quality documentation and records are completed thoroughly and timely to maintain compliance.
• Develop or assist in writing and developing quality management system processes, work instructions, and forms in conjunction with suppliers and internal purchasing control requirements.
• Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
• Hiring, managing, developing, retaining, coaching and mentoring staff including setting individual and team goals and conducting performance reviews.

You Background Should Include:

• Bachelor's degree in biological sciences or related field with a minimum of 10 years experience in medical devices or pharmaceutical supplier quality management or Quality Engineering role
• Previous experience managing and developing staff with a minimum of 8 years of experience.
• Experience auditing CMOs, CTLs, calibration, and 3PL.
• Experience with direct FDA interaction (or other regulatory agencies) required
• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• In-depth knowledge of and ability to apply GMP in conformance to the US, EU, and ROW standards
• Willingness to think outside of the box and adapt best practices to this small, but growing environment
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
• Knowledge of testing equipment, statistical methods, validation methods, problem-solving, and control plans.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description.
• ASQ's Certified Supplier Quality Professional (CSQP), Project Management (PMP) certification is preferred.
• Experience with world-class manufacturing techniques (Lean, Six Sigma, Kanban, Kaizen, etc.) is highly desired.
• Experience in working in Biotech and/or Medical Device manufacturing industry and managing new product development across the product lifecycle of conceptualization, design controls, and customer interfaces is highly desired.
• Has a proven track record of delivering results and is action-oriented.
• Travel will be required upto 25% of the time, both domestically and internationally.
• Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.