The Sr. Specialist, eQMS serves as the primary system administrator for the MasterControl electronic Quality Management System (eQMS), responsible for system configuration, user administration, lifecycle management, and continuous improvement of the platform and its governed processes. This role also serves as Training Coordinator, provides backup coverage for the Document Coordinator function, and owns the collection, reporting, and visual management of quality metrics and KPIs presented at key site forums at the LyFE site.

KEY ROLE AND RESPONSIBILITIES: 

MasterControl eQMS System Administration:

• Administer user accounts, roles, and permission groups; provision and deprovision access in accordance with site SOPs.
• Evaluate, plan, and execute system configuration changes and version upgrades; author and manage all Mastercontrol change controls through the eQMS workflow.
• Design, build, and deploy electronic form solutions within MasterControl to automate and standardize quality data capture and approvals.
• Serve as the primary point of contact for system incidents; diagnose and resolve user-reported issues and escalate complex technical problems to MasterControl vendor support as needed.

Quality System Process Support:

• Execute the Training Coordinator function within MasterControl; configure training assignments to ensure accurate mapping to job codes, roles, and user profiles.
• Maintain user training records by managing job code assignments, personas, trainer group memberships, and course curricula within the eQMS.
• Perform the Document Coordinator role in MasterControl; review and edit controlled documents for template conformance, correct formatting, and grammatical accuracy prior to release.
• Coordinate with document owners and stakeholders to meet targeted effective dates, ensuring alignment with quality event drivers and regulatory timelines.
• Partner with functional area representatives to identify new document types and configure corresponding templates within the eQMS document management module.
• Author and complete impact assessments for the document management and training sections of change controls.
• Provide system-level and procedural Quality guidance for quality events including deviations, out-of-specification, nonconformance, CAPAs, and change controls, as applicable.
• Deliver end-user training on quality system processes (CAPA, Deviation, OOS, Change Control, etc.) documented and executed within the MasterControl eQMS platform.

Quality Metrics Reporting and Visualization:

• Extract, compile, and present quality metrics and KPIs for site governance forums including Management Review, Tier meetings, and Quality Council; ensure data accuracy and traceability to source systems.
• Collaborate with IT/IS to design, build, and maintain data visualization dashboards that surface key quality metrics and trend data for site leadership and functional teams.

PREFERRED EDUCATION: 

• Bachelor’s degree (BA/BSc) or equivalent in Computer Science, Information Systems, Microbiology, Biochemistry, Chemical Engineering, Bioengineering, or a related scientific or technical field.

PREFERRED EXPERIENCE: 

• Minimum 10 years’ experience in biopharmaceutical or life sciences environments, with demonstrated technical depth in regulated GMP systems.
• Minimum 5 years’ experience in Quality Assurance and Quality Systems roles within GMP manufacturing or clinical operations.
• Proven hands on experience as a system administrator for an enterprise eQMS platform (e.g., MasterControl, Veeva Vault QMS, or equivalent); experience with system configuration, user lifecycle management, and validated system change control strongly preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

• Hands on experience administering systems in cGMP clinical or commercial manufacturing environments required; familiarity with 21 CFR Part 11, Annex 11, and computer system validation (CSV) principles preferred.
• Deep functional expertise with eQMS modules and quality event management workflows (deviations, CAPAs, change management, document control, training management) required.
• Demonstrated ability to work effectively both independently and cross-functionally with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners to define system requirements, manage project plans, and communicate outcomes to stakeholders.
• Detail-oriented and organized, with strong analytical and problem-solving skills; able to independently prioritize and manage multiple system administration tasks in a dynamic environment.
• Adaptable self-starter with a continuous improvement mindset and the ability to thrive in a fast-paced, clinical-stage biotech environment with evolving system needs.
• Excellent written and verbal communication skills; ability to translate technical system concepts for non-technical audiences and prepare clear documentation for GMP-regulated environments.

Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.

The salary range for this position is $124,000 - 155,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include flexible time off,  8 observed holidays as well as a floating holiday. We also have a winter office shutdown.

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

The incumbent is responsible for the design, execution and oversight of the supplier and vendor oversight program as well as the internal audit program. This role will be responsible for assessing GxP suppliers and executing questionnaires and audits as required. The incumbent will create and maintain the audit schedule and the approved supplier list. This is a cross-functional role that will ensure the organizations suppliers and vendors are acceptable to support GxP processes.

KEY ROLE AND RESPONSIBILITIES:

• Create the annual audit schedule, both internal and external, and report on progress against activities and timelines
• Lead cross-functional teams in the evaluation of suppliers and vendors to determine quality and criticality
• Document, track, distribute and follow-up actions resulting from supplier questionnaires captured in the Quality Management System
• Plan, execute and report on virtual and on-site audits of suppliers and vendors
• Plan, execute and report on internal audits
• Maintain the Approved Supplier List
• Support third-party audits hosted onsite
• Own and facilitate the Material Review Board
• Participate in cross-functional teams for bringing in new materials and vendors

PREFERRED EDUCATION:

• BA/BSc with a minimum of 10 years’ experience; or
• MBA or MSc with a minimum of 7 years’ experience
• Professional Auditor Certification

PREFERRED EXPERIENCE:

• Minimum 12 years’ experience in GMP biopharmaceutical operations with a minimum of 8 years’ experience in GMP Quality and a minimum of 5 years’ experience as an auditor
• Demonstrated experience in Clinical and GMP manufacturing
• Proven experience with quality management systems (e.g. Deviations, CAPA, Risk, etc)

KNOWLEDGE, SKILLS AND ABILITIES:

• Deep knowledge and understanding of the regulations that govern GMP manufacturing and specifically cell therapy companies in the US, Canada, Australia, Europe and Japan
• Ability to occasionally work non-traditional work times to support remote audits in other time zones
• Ability to travel up to 10% of the time to perform on-site audits
• Proven strong leadership, collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.
• Motivated and organized critical thinker with solid interpersonal and business communication skills
• The desire and ability to work in a fast-paced, start-up environment

The salary range for this position is $124,000 - 150,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include flexible time off,  8 observed holidays as well as a floating holiday. We also have a winter office shutdown.

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

We are seeking a highly motivated Manager, Quality Control – Cell Therapy to join our dynamic and high-performing team at the Lyell Manufacturing Facility, LyFE in Bothell, WA.  The role will be responsible for leading Quality Control operations supporting GMP manufacturing, release of cell therapy products and the transfer of analytical methods to the site. This role oversees analytical testing, environmental monitoring, laboratory compliance, data integrity, and method lifecycle management, to ensure products meet regulatory, safety, and quality standards. The QC Manager ensures adherence to cGMP, regulatory guidance, and internal quality systems while supporting clinical and commercial manufacturing.

The ideal candidate will have experience in a GMP-regulated facility with a good technical foundation in one or more of  cell-based potency, flow cytometry-based or PCR-based assays required for release testing of cell therapy products. This is an onsite role with no remote work option.

KEY ROLE AND RESPONSIBILITIES:

• Schedule day-to-day QC laboratory operations supporting release and in-process testing of cell therapy products.
• Oversee analytical assays such as flow cytometry, digital droplet PCR, sterility, endotoxin, mycoplasma, cell viability, vector copy number, and potency assays.
• Manage the Contamination Control Program for the manufacturing site
• Ensure timely testing and release of raw materials and drug product.
• Support method transfer, qualification, validation, and lifecycle management of analytical methods.
• Manage, mentor, and develop QC analysts and supervisors.
• Establish staffing plans and training programs to support laboratory operations.
• Review and approve analytical records, certificates of analysis, and laboratory documentation.
• Ensure proper maintenance and qualification of laboratory equipment. Experience with BMRAM is a plus.
• Oversee stability testing programs
• Partner with Manufacturing, QA, Regulatory, Process and Analytical Development, Manufacturing Sciences and Technology and Supply Chain to support product release and continuous improvement.

• Initiate, lead and participate in deviations, Change Controls and CAPAs.  Experience with MasterControl is a plus.
• Support regulatory filings, inspections and client audits.

PREFERRED EXPERIENCE/EDUCATION:

• BSc with a minimum of 10 years’ experience in a relevant field (e.g. Cell Biology, Immunology or Flow Cytometry)
• MSc with a minimum of 7 years’ experience in a relevant field (e.g. Cell Biology, Immunology or Flow Cytometry)
• Minimum of 10 years’ experience in cGMP biopharmaceutical manufacturing with 5+ years of experience in cell therapy
• Solid technical understanding of cell therapy release testing assays is required.
• Minimum of 5 years managing people in technical GMP roles

KNOWLEDGE, SKILLS AND ABILITIES:

• 8+ years of experience in a GMP-regulated pharmaceutical, biotech, or related industry.
• Prior experience in cell therapy environments is a must
• Strong leadership and team development skills.
• Excellent analytical and problem-solving abilities.
• Experience with electronic systems such as LIMS, ELN, or electronic batch records.
• Experience with method validation and regulatory submissions.
• Familiarity with FDA regulatory expectations for advanced therapy medicinal products (ATMPs).
• Occasional weekend work and holiday coverage will be needed
• Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible weekend work, and holiday work will occasionally be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us.  Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients
• This is an onsite role with no remote option.
• Candidates must be authorized to work in the U.S. without sponsorship.