Manager, Quality Assurance

Taylor Strategy Partners

Bothell, WA

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JOB DETAILS

SALARY

$120,000–$135,000 Per Year

SKILLS

Accidental Death and Dismemberment (AD&D), Adobe Product Family, Auditing, Biotech and Pharmaceutical, Cellular Telephone, Compensation and Benefits, Continuous Improvement, Contract Manufacturing, Cross-Functional, Current Good Manufacturing Practice (cGMP), Dental Insurance, Documentation Review, Drug Development, Drug Manufacturing, Drug Products, Employee Benefits, FDA Requirements, Federal Laws and Regulations, GMP (Good Manufacturing Practices), Insurance, Internal Audit, Keyboards, Maintain Compliance, Manufacturing, Manufacturing Analysis, Manufacturing Operations, Manufacturing Requirements, Manufacturing/Industrial Processes, Medical Products, Mentoring, Microsoft Office, Multitasking, Onboarding, Operations Control, Outsourcing, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Validation, Product Testing, Quality Assurance, Quality Control, Quality Management, Recruiting/Staffing Agency, Regulations, Regulatory Requirements, Reimbursement, Release Management/Engineering, Resume Search, Risk Management, Small Molecule Drugs, Staff Training, State Laws and Regulations, Supply Chain, Support Documentation, Systems Administration/Management, Team Lead/Manager, Test Lab, Testing, Time Management, Vaccination, Vendor/Supplier Evaluation, Vision Plan, Writing Skills

LOCATION

Bothell, WA

POSTED

Today

Description

MANAGER, QUALITY ASSURANCE

JOB SUMMARY

The Manager, Quality Assurance (QA) is responsible for managing QA activities across Curevo's clinical development programs, ensuring cGMP compliance, inspection readiness, and alignment with project and regulatory requirements within a virtual, outsourced manufacturing model. This role provides QA oversight of manufacturing, testing, and release activities performed at Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Laboratories (CTL) and ensures adherence to internal quality systems and global regulatory expectations. This position will support late-phase clinical development (Phase II/III) and Biologics License Application (BLA) enabling activities, including oversight of drug product manufacturing while coordinating timelines, risks, and cross-functional deliverables to achieve program objectives.

KEY ROLES AND RESPONSIBILITIES

Provide QA oversight of cGMP manufacturing operations and analytical testing conducted at CDMOs and CTLs
Perform QA batch record review and disposition, ensuring compliance with specifications, cGMP requirements, and regulatory expectations
Ensure compliance with U.S. and international regulatory requirements for clinical-stage products
Manage and continuously improve the Quality Management System (QMS)
Drive inspection readiness, including support for regulatory inspections and audit responses
Lead and manage deviations, CAPAs, and effectiveness checks to ensure sustainable compliance
Lead and participate in internal audits, vendor/CDMO audits, and regulatory inspections
Develop, maintain, and oversee Quality Agreements with CDMOs and CTLs
Provide ongoing QA oversight of external partners to ensure compliance with GMP and contractual expectations
Collaborate with CMC Operations, Quality Control, Regulatory Affairs, and Supply Chain to resolve quality issues and drive continuous improvement
Support program timelines, risk management, and tracking of quality deliverables
Manage and review GMP documentation supporting development, release, and lifecycle management
Lead and mentor QA staff, including training, onboarding, and professional development
Promote a strong quality culture aligned with Curevo's clinical and regulatory objectives

REQUIRED QUALIFICATIONS

BA/BS degree in science, engineering, or related field
4+ years of experience in Quality Assurance, CMC, or related field
Strong knowledge of FDA and global regulatory requirements
Expert understanding of cGMP requirements for manufacturing, analytical testing, batch review, and process validation
Experience working within an outsourced/CDMO manufacturing model

PREFERRED QUALIFICATIONS

Experience supporting small molecule drug product manufacturing, testing, and release (clinical and/or commercial)
Experience with biologics and/or vaccine programs
Experience working with EU Qualified Persons (QPs) for batch certification and EU distribution
Experience supporting regulatory inspections and audit readiness activities
Additional experience in CMC Operations or Quality Control
Advanced degree (MS or higher) in a relevant scientific discipline

KNOWLEDGE, SKILLS, AND ABILITIES

Strong expertise in GMP auditing, documentation review, and quality systems management
Excellent written and verbal communication and stakeholder management skills
Ability to work cross-functionally and influence decision-making across teams
Proficiency with electronic Quality Management Systems (eQMS), Microsoft Office, and Adobe tools
Ability to manage multiple priorities in a fast-paced, clinical-stage environment

PHYSICAL DEMANDS

Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop , kneel, crouch, or crawl. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Vision abilities required by this job include close vision. May occasionally have to lift, tug, and pull up to 25 lbs.

WORK ENVIRONMENT

This job operates in a professional office environment. This role routinely uses standard office equipment , including computers, phones, photocopiers, filing cabinets, and fax machines.

Curevo offers its employees a generous range of compensation and benefits.

The salary range for this position is $ 120,000 - $135,000 annually. The salary range may vary based on Curevo's compensation practices and an applicant's qualifications and experience.

Employees have the opportunity to earn an Annual Discretionary Bonus, as well as being eligible to participate in Curevo's Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan, and earn 1 hour of sick time for every 30 hours worked, plus 10 paid holidays per year.

At Curevo, we believe the highest-performing teams include people from diverse backgrounds and experiences who respectfully challenge one another and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Curevo is proud to be an equal opportunity employer and does not discriminate based on 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.

About Curevo Vaccine

Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.

Attention: Search Firms / 3rd Party Recruitment Agencies

The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered the property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated with hiring from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions.

About the Company

Taylor Strategy Partners

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