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Change Control Manager Jobs in Bothell, WA (NOW HIRING)

Weyerhaeuser Company

IT Program Manager - AI

Seattle, WA · On-site

$132K - $132K/yr

Change Control: Manage changes within the program, including changes in scope, requirements, or timelines. Evaluate change requests, assess their impact on the program, document change decisions, and ...

Weyerhauser Co

IT Program Manager - AI

Seattle, WA · On-site

$132K - $132K/yr

Change Control: Manage changes within the program, including changes in scope, requirements, or timelines. Evaluate change requests, assess their impact on the program, document change decisions, and ...

TriOptus LLC

Lab System Engineer

Bothell, WA · On-site

Knowledge of computer system validation, CAPA and Deviation management, change control * Demonstrated experience with logical problem solving and root cause analysis * Symantec Management or Altiris ...

Systimmune

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Manage CAPA, deviations, change control, and document control systems * Ensure training compliance and documentation across both functional areas * Support assay validation, method transfer, and fit ...

SystImmune, Inc

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Manage CAPA, deviations, change control, and document control systems * Ensure training compliance and documentation across both functional areas * Support assay validation, method transfer, and fit ...

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Change Control Manager information

See Bothell, WA salary details

$43.6K

$91.8K

$139.2K

How much do change control manager jobs pay per year?

As of Jun 26, 2026, the average yearly pay for change control manager in Bothell, WA is $91,818.00, according to ZipRecruiter salary data. Most workers in this role earn between $47,000.00 and $135,300.00 per year, depending on experience, location, and employer.

What are the typical challenges faced by a Change Control Manager when coordinating cross-functional teams during change implementation?

A Change Control Manager often encounters challenges such as aligning diverse team priorities, ensuring clear communication, and managing resistance to change across departments. Coordinating cross-functional teams requires balancing the needs and schedules of stakeholders in IT, quality assurance, operations, and regulatory affairs. Successfully navigating these challenges involves setting transparent processes, hosting regular update meetings, and fostering a culture of collaboration to ensure changes are implemented smoothly and in compliance with relevant standards.

What are the key skills and qualifications needed to thrive as a Change Control Manager, and why are they important?

To thrive as a Change Control Manager, you need expertise in project management, process improvement, and risk assessment, often supported by a relevant degree and certifications such as PMP or ITIL. Familiarity with change management software, documentation systems, and compliance tools is typically required. Strong communication, analytical thinking, and stakeholder management skills help drive successful change initiatives and mitigate resistance. These skills and qualities are crucial to ensure that organizational changes are implemented efficiently, with minimal disruption and maximum compliance.

What are the 5 C's of change management?

The 5 C's of change management are Communication, Commitment, Coordination, Control, and Competence. As a Change Control Manager, understanding these principles helps ensure effective implementation of change processes, minimizing risks and resistance. These elements are essential for managing organizational change successfully.

What do change managers get paid?

Change Control Managers typically earn a salary ranging from $70,000 to $130,000 annually, depending on experience, industry, and location. They often require strong project management skills and certifications like CCMP or PMP, which can influence compensation.

What is the difference between Change Control Manager vs Quality Assurance Specialist?

AspectChange Control ManagerQuality Assurance Specialist
CertificationsISO 9001, PMP, or equivalentISO 9001, Six Sigma, or equivalent
Work EnvironmentRegulated industries like manufacturing, pharma, biotechManufacturing, software, healthcare sectors
Primary FocusManaging change processes, documentation, approvalsEnsuring product quality, testing, compliance

The Change Control Manager and Quality Assurance Specialist roles often overlap in regulated industries, but their focus differs. The Change Control Manager primarily oversees change processes and documentation, ensuring compliance with procedures. The Quality Assurance Specialist concentrates on maintaining product quality through testing and compliance checks. Both roles require similar certifications and work environments, but their core responsibilities distinguish them within the industry.

What are Change Control Managers?

Change Control Managers are professionals responsible for overseeing and managing the process of controlling changes to projects, systems, or processes within an organization. Their main role is to ensure that all proposed changes are properly evaluated, documented, and implemented in a controlled manner to minimize risks or disruptions. They work closely with project teams, stakeholders, and quality assurance to ensure compliance with regulatory requirements and organizational standards. This role is especially vital in industries like IT, pharmaceuticals, and manufacturing, where changes can significantly impact operations or product quality.

What is the role of a change control manager?

A change control manager oversees the process of managing and documenting changes to projects, products, or systems to ensure they are implemented smoothly and with minimal risk. They review change requests, coordinate with relevant teams, and ensure compliance with quality and regulatory standards, often using tools like change management software. This role requires strong organizational skills and attention to detail to maintain system integrity and project stability.

Is change management high paying?

Change Control Managers typically earn salaries above the national average for administrative or managerial roles, with compensation increasing with experience, certifications, and industry. They often work in regulated industries like pharmaceuticals or manufacturing, where strong organizational and communication skills are essential. Overall, change management roles can be considered well-paying within the project management and quality assurance fields.
What job categories do people searching Change Control Manager jobs in Bothell, WA look for? The top searched job categories for Change Control Manager jobs in Bothell, WA are:
What cities near Bothell, WA are hiring for Change Control Manager jobs? Cities near Bothell, WA with the most Change Control Manager job openings:
Change Control Manager jobs near you
Infographic showing various Change Control Manager job openings in Bothell, WA as of June 2026, with employment types broken down into 1% As Needed, 80% Full Time, 16% Part Time, 1% Temporary, and 2% Contract. Highlights an 93% Physical, 5% Hybrid, and 2% Remote job distribution, with an average salary of $91,818 per year, or $44.1 per hour.
Principal, Quality Control

Principal, Quality Control

Lyell Immunopharma

Bothell, WA

Other

Posted 10 days ago

Job description

 

The Principal, Quality Control is responsible for providing subject matter expertise (SME) in analytical method qualification, validation, and regulatory submission authoring for cell therapy products. This role partners closely with Analytical Development, Manufacturing, MSAT, Process Development, Regulatory, and Quality Assurance to support technology transfer, method validation, and commercialization efforts including preparation for Biologics License Application (BLA) submission(s).

The incumbent will serve as a Quality Control representative on cross-functional project teams, ensuring that product-related activities are executed in compliance with GMP requirements while supporting timelines for clinical and commercial milestones.

The Principal, QC will provide scientific and strategic guidance and leadership for method validation programs, including the design, execution, and documentation of validation activities for cell-based, flow cytometry-based, and PCR-based release and stability assays. This role requires expertise in authoring CMC quality sections for IND and BLA regulatory submissions and serves as a key QC interface with Regulatory Affairs, QA, and Manufacturing during inspections and agency interactions.

KEY ROLES AND RESPONSIBILITIES:
  • Serve as the QC analytical SME for the design, development, and validation strategy for cell therapy release and stability methods, including cell-based potency assays, flow cytometry-based phenotyping, and PCR-based methods (e.g., VCN, residual plasmid).
  • Provide technical oversight for method transfers from Analytical Development or external labs, ensuring scientific rigor and regulatory acceptability.
  • Lead method qualification or validation strategy in alignment with ICH Q2(R1)/Q2(R2), ICH Q6B.
  • Evaluate method performance data critically; provide scientific justification for acceptance criteria, method parameters, and specification setting.
  • Serve as QC SME during regulatory agency inspections, partner audits, and internal GMP audits related to analytical methods and testing strategies.
  • Author CMC quality sections for IND and BLA submissions, including analytical method descriptions, method validation summaries, specification justifications, and stability program summaries (Module 3).
  • Contribute to authoring Contamination Control Strategy (CCS) sections in regulatory filings, in alignment with current regulatory expectations.
  • Act as the Quality Control representative on cross-functional project teams supporting product development, tech transfer, method validation, and commercialization activities.
  • Serve as Quality Control Subject Matter Expert (SME) for BLA coordination activities.
  • Drive continuous improvement initiatives within the QC laboratory, including method lifecycle management, assay robustness improvements, and test efficiency optimization.
  • Participate in cross-functional readiness activities to ensure the QC department is prepared for regulatory inspections as applicable.
  • Initiate, lead, and contribute to deviations, Change Controls, and CAPAs associated with QC methods, analytical instrumentation, and release testing. Experience with MasterControl is a plus.
KNOWLEDGE, SKILLS AND ABILITIES:
  • Expertise in cell therapy QC analytical methods, including flow cytometry, PCR-based assays, and cell-based functional/potency assays.
  • Comprehensive knowledge of ICH guidelines applicable to QC, including ICH Q2(R1)/Q2(R2), ICH Q6B, ICH Q1E, ICH Q9, and ICH Q14.
  • Proven capability to design and oversee execution of qualification/validation protocols.
  • Strong working knowledge of GMP-regulated laboratory operations, GDP principles, and LIMS systems.
  • Ability to work effectively both independently and cross-functionally with Analytical Development, Manufacturing, MSAT, Regulatory, Supply Chain, and external partners to set goals, develop sound project plans, monitor progress, and report results.
  • Outstanding communication, emotional intelligence and interpersonal skills.
  • Curious and proactive mindset with a continuous improvement orientation; actively seeks to understand processes, identify risks, and implement sustainable quality solutions.
  • Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
  • Excellent analytical skills and scientific/technical expertise.
PREFERRED EDUCATION:
  • or MSc. in Biology, Immunology, Cell Biology, Biochemistry, Molecular Biology, or a related life sciences field with a minimum of 15 years' experience; or 
PREFERRED EXPERIENCE:
  • 10-15 years of experience in GMP biopharmaceutical operations including 4 years in cell therapy and/or lentiviral manufacturing operations.
  • Minimum of 5+ years in Quality Control
  • Direct experience supporting BLA submissions, regulatory filings, and/or health authority inspections.
  • Experience in commercial manufacturing and post-approval lifecycle management.
  • Familiarity with contamination control principles, including Disinfection Studies, Environmental Monitoring Program and aseptic process simulation.

WEEKEND WORK AND HOLIDAY COVERAGE:

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.

The salary range for this position is between $148,000 - $185,000, 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.

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've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.

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