Senior Manager, Quality
Job in
Marlborough, Middlesex County, Massachusetts, 01752, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Senior Manager, Quality responsible for strengthening quality systems, driving continual improvement, and fostering a quality-centric culture at the Marlborough site.
Responsibilities- oversee ISO 9001 compliance, internal/external audits, CAPA, document control, and validation
- lead and develop quality team members
- monitor quality metrics and KPIs
- support audit programs
- manage investigations and nonconformances
- lead digital transformation initiatives to transition to electronic systems
- collaborate with global quality stakeholders and site leadership to implement enterprise-wide quality processes
- promote continuous improvement and risk-based decision making
- Bachelor's in Chemistry, Biology, Engineering, or related field
- 10+ years in regulated quality environments (ISO 9001, ISO 13485, cGMP)
- 4+ years of leadership experience in coaching and developing teams
- expertise in QMS, audits, CAPA, validation, and document control
- strong knowledge of GDP, root cause analysis, and quality investigations
experience with digital quality system transformation, lean or operational excellence methodologies.
High-valuestrategic quality leadership within biopharma manufacturing, supporting biologics or other biologic modalities, with a focus on compliance, continuous improvement, and digitalization.
Work setupnot specified, but involves cross-functional partnership and leadership.
Position Requirements
10+ Years
work experience
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