Senior Quality Assurance Manager

Dexian; Washington (Washington County); On-site; USD 89,544 - 96,432; Full time

Job summary

Dexian, a leading biotechnology organization, seeks an experienced GMP Operational Quality Sr. Manager to drive quality assurance and compliance in a biologics manufacturing environment.

You will provide technical leadership for quality systems, investigations, CAPA, change control, supplier quality, and regulatory compliance while partnering with internal teams and CMOs. The role focuses on leading investigations of deviations, OOS events, reviewing batch records, maintaining quality metrics,

Qualifications

• 6+ years of QA experience in biologics/pharma manufacturing.
• Bachelor's degree in a scientific/health field.
• Strong knowledge of cGMP and global GMP regulations.
• Experience leading CAPA, Change Control, RCA, deviations, and investigations.
• Experience supporting CMO quality oversight.

Responsibilities

• Collaborate with internal teams and CMOs to resolve quality issues.
• Draft and manage Quality Agreements with CMOs and suppliers.
• Review and approve Change Controls; lead investigations of deviations and OOS.
• Maintain Quality Metrics and perform quality risk assessments.
• Support regulatory inspections and internal audits.

Skills

Quality Assurance

Leadership

Regulatory compliance

Quality systems

Education

Bachelor's degree in a scientific field

Tools

TrackWise

Veeva

QDocs

Job description

Quality Manager opportunity with a leading biotechnology organization

Biotech Quality Manager

Location: Pacific Northwest region, WA

6 to 18 Months contract to start

Pay range :$65-70/hr

Position Overview

We are seeking an experienced GMP Operational Quality Sr. Manager to support quality assurance and compliance activities within a biologics manufacturing environment. This position will provide technical leadership for quality systems, investigations, change control, CAPA, supplier quality, and regulatory compliance while partnering with internal teams and Contract Manufacturing Organizations (CMOs).

Responsibilities

• Collaborate with internal teams and external manufacturing partners to resolve complex quality issues.
• Support cross-functional quality initiatives.
• Draft and manage Quality Agreements with CMOs and suppliers.
• Review and approve Change Controls.
• Lead investigations involving deviations, OOS events, and product impact assessments.
• Review and approve CAPAs.
• Review master and executed batch records supporting drug substance, drug product, and finished goods.
• Maintain Quality Metrics.
• Identify compliance gaps and implement process improvements.
• Review GMP documents, SOPs, work instructions, protocols, and specifications.
• Support regulatory inspections and internal audits.
• Perform quality risk assessments.

Required Qualifications

• Bachelor's degree in a scientific or allied health field (or equivalent).
• 6+ years of Quality Assurance experience within biologics or pharmaceutical manufacturing.
• Strong knowledge of cGMP and global GMP regulations.
• Experience leading CAPA, Change Control, RCA, deviations, and investigations.
• Experience supporting CMO quality oversight.
• Experience with electronic quality systems such as TrackWise, Veeva, or QDocs.
• Strong communication and leadership skills.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.