Sr. Manager, R&D Quality
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Senior Manager, R&D Quality at a biopharma focused on autoimmune and rare diseases, overseeing quality assurance activities across clinical development.
Responsibilities
- manage the Quality Management System
- conduct audits (investigator, vendor, systemic)
- support inspection readiness
- oversee vendor qualification and oversight
- ensure data integrity and TMF compliance
- author SOPs
- lead process improvements
- promote a quality culture through training
- Bachelor's in Life Sciences or related field
- 8+ years of biotech/pharmaceutical R&D QA experience
- deep knowledge of FDA, ICH, and EMEA regulations
- strong leadership, communication, and project management skills
- proficiency in GxP standards and Microsoft Office
- experience in clinical QA within biotech/pharma
- familiarity with GLP, GCP, GVP, and risk-based quality management
- hands‑on with audits, vendor oversight, inspection support, and data integrity in clinical systems
- focused on cGMP compliance and continuous improvement
office-based in Waltham, MA, with a 3-day in-office requirement per week.
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