Principal, Quality Assurance
$150,000–$185,000 year
On-siteBothell, Washington, United States
Job Summary
Provide CDMO Quality oversight for process validation (PPQ) activities for Lenti Viral Vector, Plasmids, and Drug Products, ensuring execution aligns with approved protocols, GMP requirements, and regulatory expectations. Review and approve validation protocols, reports, and supporting documentation while partnering with Manufacturing, MSAT, and Process Development to define robust validation strategies. Serve as the Quality representative on cross-functional project teams supporting IND/BLA coordination, CMC section authoring, and inspection readiness, ensuring all documentation is accurate and compliant. Act as the Quality Subject Matter Expert for regulatory submissions and drive continuous improvement initiatives to enhance process robustness and validation effectiveness.
Required Qualifications
- Experience in cGMP clinical manufacturing
- Experience with electronic quality management systems (e.g. deviations, CAPAs, change management)
- Proven capability to oversee QA operations and workflows, ensuring timely execution, compliance, and alignment with organizational priorities
- Ability to work effectively both independently and cross-functionally with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners to set goals, develop sound project plans, monitor progress, and report results
- Excellent 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
- BS with a minimum of 15 years experience in biochemistry, chemical engineering, bioengineering, or related scientific field
- 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 Assurance
- Direct experience supporting BLA submissions, regulatory filings, and/or health authority inspections
- Experience in commercial manufacturing and post-approval lifecycle management
- Must be able to do the following: Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product
- A vision test may be required
- Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns
- Shift work, weekend work, and holiday coverage will occasionally be required
Desired Qualifications
- Experience with Plasmid and LVV manufacturing
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