Genentech · 20 hours ago
Head of Quality Systems Validation (Director/Senior Director)
Hillsboro, OR
Full-time
Onsite
Director/Executive
$142K/yr - $264K/yr
12+ years expGenentech is a leader in cell and gene therapy manufacturing, and they are seeking a Head of Quality Systems Validation to architect a world-class QSV framework. This role involves leading a high-performance team, ensuring compliance with cGMP regulations, and driving innovation in a dynamic environment.
BiotechnologyLife ScienceManufacturing
Responsibilities
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
Qualification
Required
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
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
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 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
Work in office and laboratory environment
Lift up to 25 lbs may be required
Ability to sit, stand and move within work space for extended periods
May be required to sit at a computer terminal for extended periods
Ability to travel up to 30% to other sites as required
Preferred
Cell therapy industry experience is preferred
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are approved for this posting.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President
Recent News
2026-01-07
MarketScreener
2026-01-06
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