Head Quality Systems and Quality Validation (Director)

The Position

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 Quality Systems and Validation, you will drive the design, implementation, and operation of robust QSV strategies to enable the support of a cutting-edge GMP facility for high-throughput manufacturing. This role requires strong collaboration across functions and sites to support rapid product disposition, regulatory compliance, and next-generation production goals. Key responsibilities include:

• Leading the design and implementation of comprehensive Quality Systems and Validation strategies aligned with cGMP regulations and project milestones.
• Building and managing an agile, autonomous team capable of addressing operational and business challenges while fostering a culture of collaboration, experimentation, and continuous improvement.
• Leading and overseeing all Quality Engineering Validation activities, including equipment, methods, facilities, utilities and computer systems.
• Partnering with regulatory agencies, external stakeholders, and internal teams to ensure regulatory submissions, inspections, and audits are successfully completed.
• Proactively identifying and resolving quality issues, including investigations and corrective actions, to maintain project timelines and deliverables.
• Supporting the transfer and validation of products and assays to enable production and meet timeline demands.

Who You Are:

• You possess a Bachelor's degree or higher in Chemistry, Biochemistry, or a relevant scientific discipline along with 12 or more years of progressive 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.

Preferred:

• Cell & Gene therapy experience

Physical Requirements:

• 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

The expected salary range for this position based on the primary location of Oregon is $142,000 - $263,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link.

Relocation benefits are approved for this posting.

This is an on-site position; no remote options are offered at this time.

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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