Job Description: QA Lead Technical Operations, Projects
Remote · Devens, Massachusetts, United States
Job Summary
QA Lead Technical Operations, based at Devens (MA) with remote-capable work arrangement, provides QA support to Investigations, CAPAs, and quality systems; reviews/approves QA, QC, validation, and automation documents; approves SOPs, validation documentation (risk assessments, protocols, test scripts, and summary reports); reviews change proposals to ensure alignment with external/regulatory guidelines; coaches across departments in Investigations, CAPAs, risk assessments, and Validation; self-manages multiple deliverables in a remote work environment; interacts with Reporting Manager and cross-functional teams including Manufacturing Operations, MS&T, Validation, and Site Engineering; requires BS-level education and 8+ years GMP/GXP quality experience; deep knowledge of cGMPs and data integrity; comfortable with electronic systems (SAP, LIMS, TrackWise, Veeva Vault) and problem-solving.
Required Qualifications
- B.S. in Biological science, Engineering, biochemistry, or related discipline (or equivalent)
- 8+ years of GMP/GCP/GXP experience focused on product quality
- Experience with QC equipment qualification and project management
- Knowledge of biotech, bulk drug substance or finished product manufacturing; medical device analytical testing desirable
- Extensive knowledge of US and EU cGMP regulations and guidance (GAMP 5)
- Knowledge of electronic systems (SAP, LIMS, TrackWise, Veeva Vault) or batch records (electronic or paper)
- Strong technical writing and oral communication skills
- Comfortable in FDA-regulated environments
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