Raw Materials Compliance Manager
Greater Boston Area
Looking to elevate your career to the next level with an industry leading patient-focused biopharmaceutical company? A Top-10 pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines in Neuroscience, Oncology, and GI is currently seeking a Compliance Specialist as their company is rapidly expanding! This company has received recognition for their overall success and is looking to increase headcount within the Quality Department. Now is a pivotal time to get in with this group as you will have the ability to lead and impact their robust pipeline of promising new medicines.
Key Responsibilities:
- Understands and makes informed decisions pertaining to testing
- Review, manager and ensure compliance with GMP regulations for raw materials pertaining to commercial manufacturing
- Works with different project teams to on-board raw material
- Serves as the SME for internal and external customers on technical transfers
- Update and modify SOPs as required to ensure compliance
- Keeps up to date with compliance and regulation guidelines within the industry
Ideal Candidate Must Have:
- 5+ years of QA experience in the pharma/ biotech industries
- 3+ years of biologics experience
- 3+ years of experience working with raw materials
- 3+ years of experience working with SAP, or a similar system of function