Job description

Manager of Quality Assurance

Biotechnology

Redmond, WA

$110,000- $130,000 + 15% annual bonus

Start Date: ASAP

Description:

We are working with a biotechnology company who are looking for a Manager of Quality Assurance to support the development & operation of the Washington facility. This company has a global presence and is striving to be the #1 biotechnology company in the world.

Responsibilities:

• Strategize QMS and establish quality procedures to support production on site.
• Provide cross-site quality leadership to quality systems lifecycle maintenance, raw material and final product release, supply chain, automation, manufacturing, validation and facility engineering.
• Utilise Quality by Design principles to define a robust, integrated control strategies of the mRNA and synthetic DNA manufacturing process.
• Manage the execution of quality systems during daily production activities to ensure the delivery of high quality products.
• Prepare and execute regulatory and client inspections, host audits and responsible for corrective action plans.
• Present updates to project or upper management teams on progress and enforcement of quality improvement and manufacturing support activities.
• Review and approve SOPs (Standard Operating Procedures), reports and risk assessments, and work to improve application and standardization of phase appropriate processes and curricula.

Requirements:

• Master’s degree, in Biotechnology related field with 5+ years of Quality Assurance or Quality Control experience in a production facility with management.
• Completed Lead Auditor training for any standard (preferably ISO 9001, ISO 13485 and/or relevant regulatory requirements). Prior audit experience is preferred.
• Extensive knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, EudraLex Vol. 4, and other regulations that govern GXP compliance during clinical development and commercialization of drug candidates.
• Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
• Experience with gene and cell therapy products or mRNA products highly desirable.
• Proven track record in establishing a quality organization
• Management of Quality staff a plus.
• Experience in USFDA and ISO auditing and ability to lead team to successful audits.
• Versed in phase appropriate practices of clinical vs. commercial manufacturing requirements.
• Experienced in building & maintaining relationship between QA and other areas.
• Experience in CMC regulatory requirements for FDA and EMA preferred.

Job Type: Full-time

Salary: $110,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Vision insurance

Schedule:

• 10 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Bellevue, WA: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Application Question(s):

• Do you require visa sponsorship?

Experience:

• QA/QC: 5 years (Preferred)
• Biotechnology: 3 years (Preferred)

Work Location: One location

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