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Assoc Director, Quality Assurance (Global Supplier Quality)

United States - California - Foster CityQualityRegular
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Job Description

We are seeking a dynamic and experienced Associate Director to join the Global Supplier Quality team within External Quality Operations. This leadership role will provide strategic direction and operational oversight for biologics-related material categories (e.g., single-use systems, resins, filters, media, excipients). The Associate Director will serve as a key quality leader, driving supplier performance, risk mitigation, and lifecycle management across a global network. This role requires strong technical expertise, external relationship management, and the ability to influence cross-functional teams and senior stakeholders.

Job Responsibilities

  • Provide strategic quality leadership for biologics material suppliers across internal and external manufacturing networks

  • Lead supplier investigations, deviations, and CAPAs, ensuring timely resolution and systemic improvements

  • Oversee supplier-initiated changes and global change notifications, including impact assessments and cross-functional implementation

  • Drive supplier selection, onboarding, and lifecycle management in collaboration with Quality, Supply Chain, Technical Development, Manufacturing Operations

  • Lead negotiation and governance of Quality Agreements with key suppliers and internal partners

  • Monitor supplier performance, risk indicators, and compliance trends; present insights to senior leadership

  • Ensure data integrity and alignment of supplier master data in SAP and related systems

  • Oversee and ensure timely, high-quality responses to audit observations, collaborating with internal and external stakeholders to drive sustainable remediation and readiness

  • Apply quality risk management principles across materials and supplier decisions

  • Lead or support cross-functional initiatives to optimize raw material and supplier lifecycle management, with a focus on risk mitigation, compliance, and continuous improvement

  • May manage and mentor team members depending on organizational needs

  • Travel may be required up to 20%

Basic Qualifications

  • BA/BS degree and 10+ years of relevant experience; OR​

  • MA/MS degree and 8+ years of relevant experience; OR

  • PhD/PharmD and 5+ years of relevant experience

  • Degree in science or engineering with relevant GMP experience

  • Demonstrated leadership in managing external suppliers in a regulated environment

  • At least 4+ years of experience overseeing CDMOs or suppliers

Preferred Qualifications

  • Deep understanding of biologics manufacturing and raw material categories (e.g., SUS, filtration, extractables/leachables)

  • Experience with Quality Management Systems, regulatory inspections, and supplier audits

  • Strong cross-functional collaboration skills with experience influencing at multiple organizational levels

  • Strong understanding of incoming material inspection processes, including sampling strategies (e.g., AQLs), certification protocols, and their application in biologics manufacturing

  • Proficiency in SAP or similar ERP systems

  • Exposure to FDA inspections, mock audits, and quality systems assessments

  • Background in process development, manufacturing, or technical development is a plus

  • Proven ability to lead in a fast-paced, evolving environment with a strategic mindset