What are the responsibilities and job description for the Quality Assurance Operations Manager position at TalentBurst, Inc.?
Industry : Pharmaceuticals
Title : Quality Assurance Operations Manager
Job ID : 2025-8807
Location : Cambridge, MA OR 100% Remote
Duration : 12 months contract ( Chances of extension)
Location : Cambridge, MA - Hybrid 2-3x per week onsite preferred but open to remote (can sit anywhere in US). Remote workers will work EST time zone.
Overview
The Manager of Quality Assurance Operations will work within the DP / CMC / Alliance QA Operations team and is responsible for providing support to all GMP aspects of drug product (DP) manufacturing, CMC and alliance management. This role will work cooperatively with their counterparts in Quality Operations to provide quality oversight to ensure clinical through commercial lifecycle activities meet cGMP regulatory requirements and guidelines. This position reports to the Director of Quality Assurance.
Key Responsibilities
- Execute quality oversight of external manufacturing of both clinical and commercial drug product through lot disposition
- Provide QA review and approval of internal and external Deviations, Change Controls, CAPAs.
- Provide QA support for review and data verification of clinical regulatory filings
- Engage with alliance partners to assure compliance to their quality systems and practices as related to manufacturing through disposition of drug product. Support establishment of best practices with alliance partners
- Collaborate and support internal colleagues and external vendors to navigate complex quality issues, ensuring compliant solutions are explored and meet patient needs.
- Ensure timely and accurate metrics reporting for KPI and risk register tools
- Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.
Qualifications
TB_PH
