Senior Manager, Clinical Quality Assurance Compliance (Remote)
BioNTech
- Cambridge, MA
- Permanent
- Full-time
- Support and collaborate with key stakeholders in a study team to ensure that risks are detected and remediated.
- Provide guidance to day-to-day questions arising from Clinical trial deliverables.
- Interact with CROs to ensure adequate quality oversight on clinical activities.
- Provide guidance to Clinical Development Operations to support initiatives relevant to outsourced activities.
- Support inspection preparation activities in collaboration with other QA functions.
- Provide support for audits and inspections, as well as, follow-up activities including CAPA preparation.
- At least 3-5 years of experience in Good Clinical Practice (GCP) and/or Quality Assurance Environment in Pharmaceutical Clinical Development or Clinical Research Organization.
- Knowledge of worldwide regulations (including FDA, EMA) related to clinical development and post approval.
- An academic degree in Life Science