Head of Quality Systems Validation (Director/Senior Director)

Genentech-posted 3 days ago
Full-time • Director
Onsite • Hillsboro, OR
5,001-10,000 employees
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Genentech’s Hillsboro Oregon campus—Hillsboro Innovative Therapies (HIT)—serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech’s mission to bring transformative therapies to patients. This role is a part of our Quality Systems and Validation (QSV) team, which is dedicated to supporting the design, startup, and operation of a cutting-edge GMP facility. As a member of this team, you will collaborate closely with stakeholders across Clinical Facilities, Technical Development, and Global Quality to define and implement robust Quality Systems, Validation strategies, and automated QC methods that ensure compliance with cGMP regulations and enable instantaneous product disposition. You will play a pivotal role in driving innovation, fostering a continuous improvement mindset, and shaping processes for next-generation production in a dynamic and engaging environment. The Opportunity: As the Head of QSV, you will serve as a pivotal strategic architect, designing and orchestrating a world-class QSV framework for a cutting-edge, high-throughput GMP manufacturing facility. This is not merely a compliance role; it is a leadership mandate to bridge the gap between innovative engineering and regulatory excellence. You will act as a primary influencer across the global network, harmonizing complex stakeholder interests to enable rapid product disposition and next-generation production goals. Key strategic responsibilities include:

  • Architecting and leading a scalable Quality Systems and Validation roadmap and strategy aligned with cGMP regulations and project milestones.
  • Championing quality as an enabler mindset by building a high-performance team of subject matter experts who serve as strategic consultants to the business, rather than just compliance enforcers.
  • Cultivating high-trust relationships with global regulatory stakeholders to influence emerging standards and ensure the facility remains at the forefront of “Quality by Design" principles and acting as a key liaison between R&D, Clinical, and Commercial operations to harmonize quality standards across the product lifecycle, effectively navigating competing priorities.
  • Leading complex, multi-functional task forces to resolve systemic quality challenges, utilizing data-driven storytelling to influence stakeholders toward sustainable, long-term corrective actions (CAPA) that enhance operational throughput.
  • Proactively identify and resolve systemic quality challenges using data-driven storytelling and expert negotiation to align stakeholders on corrective actions that maintain both project timelines and the highest safety standards.
  • Drive the standardization of validation excellence across the enterprise, influencing cross-site communities of practice to ensure that local innovations are scaled into global best practices.
  • You possess a Bachelor’s degree or higher in Chemistry, Biochemistry, or a relevant scientific discipline along with 12 or more years of progressive leadership experience in Quality Systems and Validation within the pharmaceutical or biopharmaceutical industry; cell therapy industry experience is preferred.
  • You have extensive knowledge and practical experience in developing and implementing Validation and Qualification policies, procedures, and testing methods in compliance with cGMP regulations and industry standards.
  • You have demonstrated experience with writing, reviewing, and approving complex technical documentation such as equipment qualification protocols, validation reports, life cycle documents, and Quality System policies.
  • You have a successful track record of leading cross-functional teams and managing stakeholders in a highly matrixed, dynamic environment to meet project goals.
  • You possess a deep understanding of cGMP regulations, quality systems, and validation principles with a track record of successful regulatory inspections and submissions.
  • You are a strong communicator with exceptional interpersonal skills to foster effective collaboration across internal and external partners.
  • You are skilled with prioritizing competing demands, allocating resources efficiently, and delivering results in a fast-paced start-up setting.
  • You possess a Bachelor’s degree or higher in Chemistry, Biochemistry, or a relevant scientific discipline along with 15 or more years of progressive leadership experience in Quality Systems and Validation within the pharmaceutical or biopharmaceutical industry; cell therapy industry experience is preferred.
  • You have a proven history of navigating the complexities of large-scale, high-throughput biopharmaceutical manufacturing environments.
  • Beyond practical experience, you are an SME in architecting and scaling Validation and Qualification policies from the ground up. You have a sophisticated understanding of how to translate global cGMP regulations and ICH guidelines into lean, agile operational workflows.
  • You have a distinguished track record of serving as the final technical authority for complex documentation, including Master Validation Plans (MVPs), lifecycle strategies, and site-wide Quality policies. You are adept at defending technical rationales to internal executive committees and external regulatory bodies.
  • You possess a significant track record of influence within highly matrixed, global organizations. You have successfully led multi-disciplinary teams through complex transitions, demonstrating the ability to align disparate departmental goals (R&D, Ops, IT, Legal) under a unified quality vision.
  • You are a veteran of the "front room," with a proven track record of leading successful interactions with the FDA, EMA, and other global health authorities. You don't just pass inspections; you build the organizational "inspection readiness" muscle that minimizes business risk.
  • You are an exceptional communicator with the executive presence required to brief C-suite leadership and the interpersonal nuance to build high-trust partnerships with external vendors and industry consortiums.
  • You are a specialist in strategic resource modeling, capable of prioritizing high-stakes deliverables in a volatile, fast-paced "start-up" or "scale-up" setting. You possess the emotional intelligence and decisiveness to lead through ambiguity and rapid organizational change.
  • You have significant experience overseeing the validation of next-generation technologies, including automated high-throughput systems, MES, and AI-driven data integrity platforms, ensuring that "Quality 4.0" is integrated into the site DNA.
  • cell therapy industry experience is preferred.
  • cell therapy industry experience is preferred.
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