What are the responsibilities and job description for the Senior Manager, Quality Systems Readiness (Commercial Launch) position at JMD Technologies Inc.?
Title: Senior Manager, Quality Systems Readiness (Commercial Launch)
Location: Greater Boston Area, MA (Hybrid 3 days onsite)
Employment Type: Contract
Status: Accepting Candidates
About the Role
This role supports commercial launch readiness by ensuring GMP Quality Systems and documentation are compliant, inspection-ready, and aligned with global regulatory expectations. You will partner cross-functionally and with external suppliers to drive quality execution for biologics and combination products.
Key Responsibilities
- Lead GMP Quality Systems readiness activities for commercial biologics and combination products
- Own and revise SOPs / controlled documents with heavy hands-on involvement
- Manage document lifecycle, change controls, and approvals in Veeva Vault QMS
- Ensure compliance with global GxP regulations (21 CFR, EU Annex 1, ISO 13485)
- Partner with Manufacturing, Supply Chain, Regulatory, and QA for launch execution
- Provide supplier and CMO quality oversight, including readiness and inspections
Qualifications
- 8 years of experience in Quality Assurance / Quality Systems within biotech or pharma
- Strong background in commercial biologics and/or combination products (pre-filled syringes preferred)
- Demonstrated expertise in SOP authoring, revision, and governance
- Hands-on experience with Veeva Vault QMS
- Solid understanding of GMP and global regulatory requirements
- Proven ability to work cross-functionally in fast-paced environments
Compensation (MA Pay Transparency):
- Estimated hourly range: $70–$75/hr (W-2)
- Final rate within this range will be based on skills, experience, and interview results
Salary : $70 - $75