Kyowa Kirin Senior Consultant - Digital QA
Sanford
NC
Contract Full-Time
Senior Digital QA Consultant (Validation) — Sanford, NC
BCTG's client is running a project for a pharmaceutical manufacturer in Sanford, NC and is adding a Senior Digital QA consultant to support Engineering Run readiness. This is a 6-month contract starting late September, onsite in Sanford on a weekly basis. Only local candidates will be considered.
You will serve as Digital QA alongside the client's Digital Lead across ERP, MES, PCS, and NYMI band systems supporting ER1. Day to day, that means quality oversight and risk-based review, validation and qualification support, change control input, and driving readiness decisions and the documentation behind them. You will work directly with client leads and own Finance-of-quality questions through to a decision rather than handing them off.
What we're looking for:
- 10+ years in pharma/biotech quality or validation, with GxP computerized systems experience
- Hands-on validation and qualification of ERP, MES, or PCS platforms
- Risk-based review and change control in a regulated manufacturing environment
- Comfortable operating as the senior quality voice in a room with client leads