The Manager, Quality Assurance, GCP evaluates, maintains and enhances Quality Compliance activities to ensure that Boston Biomedical Quality and Compliance Standards and applicable Government Regulations are met, and vendors achieve, maintain and improve the current level of compliance.
- Facilitates the Development, implementation and maintenance of QA systems and SOPs for GCP activities.
- Supports daily and end-to-end compliance aspects of the portfolio of GCP focused vendors in a virtual work environment.
- Works with internal GCP customers and develop and execute strategic audit plans.
- Coordinates, develops, maintains and/or provides GCP training.
- Maintains relevant knowledge of both local and international auditing and appropriate GCP requirements and developments as they impact Boston Biomedical’s SOPs and compliance with GCP, and communicate these to QA management, as applicable.
- Provides extensive experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GCP auditing.
- Provides expertise in GCP regulations and guidance for FDA and International agencies including ICH guidelines.
- Stays current with industry best practices and regulatory guidance.
- Plans, prepares, performs and reviews audits according to the audit schedule.
- Trending audit findings.
- Reviews clinical deviations and clinical deviation trends.
- Ensures the establishment of an appropriate audit responses and timescale of corrective actions in cooperation with vendors and stakeholders.
- Monitors vendor corrective and preventive actions.
- Supports the Internal Audit Program.
- Participates in Inspection Readiness activities including FDA "Mock" inspections, training and support activities.
- Supports Regulatory and Third-Party Inspections.
- Ensures Risk Registrars are prepared and maintained for Clinical Studies (CRO and Boston Biomedical issues) and Drug Program issues.
- Other GCP related tasks, as assigned.
- BA in science or equivalent with at least 8-10 years relevant experience in the Pharmaceutical Industry
- In-depth knowledge of Pharmaceutical regulations: GCP, GDP, PV, and Health regulations (ICH, FDA, EU, main local regulations, ISO).
- In-depth knowledge of Pharmaceutical Operations
- Thorough experience auditing GCP regulated areas
- Experience in FDA Regulatory Inspection support
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org