What are the responsibilities and job description for the GMP Operational Quality Senior Manager position at JMD Technologies Inc.?
About the job
Title: GMP Operational Quality Senior Manager
Location: Seattle, WA (Hybrid – 3 days onsite/week)
Employment Type: Contract
Status: Accepting Candidates
About the role
We are seeking an experienced GMP Operational Quality Senior Manager to support quality assurance and compliance activities within a biologics manufacturing environment. The ideal candidate will have strong expertise in GMP quality systems, CMO oversight, tech transfer, and quality investigations while ensuring compliance with regulatory and quality standards.
Key Responsibilities
- Support GMP quality assurance and compliance activities
- Manage quality activities with Contract Manufacturing Organizations (CMOs)
- Support technology transfer and Drug Substance (DS) validation
- Draft and maintain Quality Agreements with suppliers and CMOs
- Lead change controls, deviations, investigations, RCA, and CAPA activities
- Review and approve batch records, GMP documents, protocols, and reports
- Support internal and external audits
- Identify quality risks and implement mitigation strategies
- Maintain quality metrics and drive continuous process improvements
- Provide QA guidance to cross-functional teams and complex projects
- Utilize quality systems such as TrackWise, Veeva, and QDocs
Qualifications
- Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacy, or a related scientific field
- 6 years of GMP Quality Assurance experience in the pharmaceutical or biotechnology industry
- Strong experience with biologics manufacturing and GMP compliance
- Experience managing CMO relationships and Quality Agreements
- Hands-on experience with Tech Transfer and Drug Substance (DS) validation
- Expertise in Change Control, Deviations, Investigations, RCA, and CAPA
- Experience reviewing batch records and GMP documentation
- Experience with electronic quality systems such as TrackWise, Veeva, or QDocs
- Excellent communication, collaboration, and problem-solving skills
Compensation:
$75/hour on W2
Salary : $75