Roche · 1 month ago
Environmental/Sterility Quality Assurance (EQA) Specialist
Hillsboro
Full-time
Onsite
Senior Level, Lead/Staff
$94K/yr - $175K/yr
10+ years expRoche is a leading company in cell and gene therapy manufacturing, with a campus in Hillsboro, Oregon. The Environmental/Sterility Quality Assurance (EQA) Specialist will play a crucial role in ensuring contamination control and regulatory compliance, collaborating with various teams to uphold product quality and patient safety.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
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
Qualification
Required
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
You possess experience with investigational medicinal products, product development, phase-appropriate approaches, and multiple manufacturing technologies and product lifecycles
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed in this link.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche 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 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
Recent News
The Express Tribune
2026-01-11
2026-01-11
2026-01-11
Company data provided by crunchbase