Our client, a top-tier pharma, has engaged us to recruit a Program Manager, R&D Quality Assurance (Clinical/GCP).
- Responsible for collaborating to develop and implement a strategic audit plan for the development of all assigned compounds. Ensure that activities are conducted and reports written according to applicable regulations and company SOPs.
- Lead domestic and international audits of clinical investigator sites, documents, databases, vendors, and internal systems to assure compliance with the Code of Federal Regulations, local regulations, ICH and company policies and procedures. Audits conducted will require advanced auditing skills and will include the most technically complex assignments, including audits of potentially high risk.
- Obtain audit responses from functional areas and/or vendors, and evaluate proposed corrections, corrective actions, and/or preventive actions for compliance with applicable regulations, guidelines, and company policies. Facilitate risk remediation. Escalate inadequate audit response to senior CQA management.
- Lead investigations into scientific misconduct and/or serious breach of GCP. Analyze investigation findings to identify root/probable cause. Propose, document, and track appropriate corrective actions. Assure reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
- Participate in the development and implementation of a comprehensive training program for CQA. As appropriate, monitor and document Compliance Specialist / Associate Compliance Specialist progress against the training program.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.