Environmental/Sterility Quality Assurance (EQA) Specialist

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 vital part of our Environmental/Sterility Quality Assurance team, dedicated to ensuring the highest standards of contamination control, sterility assurance, and regulatory compliance for advanced therapeutic medicinal products. As a member of this team, you will collaborate closely with cross-functional groups, including Manufacturing, Quality Control, Facilities, and Regulatory, to uphold patient safety and product quality. Joining this team means contributing to innovative manufacturing processes, enhancing sterility programs, and shaping a culture of continuous improvement and excellence.

The Opportunity
As an Environmental/Sterility Quality Assurance (EQA) Specialist, you will play a pivotal role in shaping and driving the contamination control strategy, sterility assurance programs, and ensuring regulatory compliance for the HIT facility. Your contributions will safeguard product quality and patient safety while fostering collaboration across a highly matrixed environment.

• Support the implementation and execution of site-level Contamination Control Strategy (CCS) programs, such as environmental monitoring, aseptic processes, utility systems, and HVAC qualifications.

• Provide technical assessment, oversight, and approval of CCS and sterility assurance-related systems, ensuring alignment with cGMP, ATMP GMPs, USP, EP, and JP standards.

• Collaborate with manufacturing, quality, and facility teams to develop unified strategies for contamination control and sterility assurance while ensuring compliance with regulatory requirements.

• Offer Quality oversight for routine environmental monitoring and aseptic process simulations, ensuring programs meet regulatory and operational standards.

• Act as a key resource for regulatory submissions and facilitate interactions with regulatory agencies by advancing site sterility assurance programs.

• Drive continuous improvement initiatives by recommending enhancements to contamination controls, personnel training, and operational processes.

• Serve as a subject matter expert (SME) in sterility assurance principles and practices, providing guidance to cross-functional teams and training them as needed.

Who You Are
A seasoned Quality professional with 10+ years of experience in a regulated industry (e.g., pharmaceutical/biopharmaceutical or medical device), including a minimum of 4 years in Quality, Compliance, Regulatory, or Validation.

• You possess a Bachelor's degree in life sciences or related scientific discipline

• You possess 5 or more years of experience in a regulated industry (e.g., pharma/biopharmaceutical or medical device) along with at least 4 years in Quality, Compliance, Regulatory, and/or Validation.

• You have a strong understanding of quality assurance concepts, including cGMP, ATMPs, contamination control principles, sterility assurance programs, and ATMP-specific standards.

• You have large molecule and/or ATMP drug product manufacturing and expertise in risk-based approaches to compliance and sterility assurance processes.

• You have a proven ability to collaborate effectively in a matrixed environment and manage stakeholders across diverse teams.

• You are a skilled communicator with the ability to influence, coach, and partner with multidisciplinary stakeholders to achieve organizational goals.

Preferred Experience

• You possess experience with investigational medicinal products, product development, phase-appropriate approaches, and multiple manufacturing technologies and product lifecycles.

The expected salary range for this position based on the primary location of Oregon is $94,000 - $174,600. 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 not 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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