50% of the Time
Execute the overarching strategy related to proactive and sustainable compliance for the assigned programs. Active advisor/consultant in compliance related matters for assigned programs/projects. Active participant as QA&C representative in study team meetings, as appropriate. Support program and project teams in implementing corrective and preventive actions. Support project teams to be inspection ready within a culture of sustainable compliance. Provide/present, as required, the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management. Act as a trusted advisor, often on complex issues that lack precedence or are not clearly defined. Develop and/or review SOPs, Policies, Charters, etc. as needed. Mentor and assist QA&C representatives and/or other programs on compliance issues, as needed. Provide regulatory interpretation of impact/application to operation procedures of new/current regulations, guidelines, trends, etc.
25% of Time
Create and Execute Program Compliance and Audit Plan
Develop the audit strategy for assigned programs. Lead the execution of the audit activities associated to GCP, GPP, and applicable regulatory requirements. Assume the SOP defined ’Program Lead’ roles and responsibilities. Collaborate with key stakeholders from program teams, Audit Coordinators and/or other Program Compliance colleagues to ensure audit plan execution. Ensure the corrective and preventive actions are appropriate and completed in a timely manner. Oversee the timely development and distribution of audit reports and follow up actions. Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical noncompliance and/or lack of urgency in remediation to senior management Mentor and provide support regarding audit process.
10% of Time
Provide management and oversight to auditors contracted to provide auditing services for assigned programs. Coordinate with Quality Operations audit support staff, as required. Participate in due diligence activities, as requested. Participate in process improvement initiatives, as requested. Work closely with supervisor to manage current issues and anticipate upcoming auditing needs outside of assigned programs. As needed, may act as a supervisor for temporary contractors.
15% of Time
Regulatory Agency Inspection Support
Leads and manages the execution of strategies for the preparation, hosting and responses to regulatory agency inspections for GCP/Sponsor Monitor inspections and investigator site audit inspections for assigned programs. Host or cohost regulatory inspections, as needed
Education and Experience Requirements
- Bachelor’s degree required with a life science focus preferred; Masters Degree in management or scientific discipline a plus.
- A minimum of 10 years of relevant pharmaceutical experience.
- Ideal candidate will have broad experience in product development, clinical operations, regulatory comp
Location/Region: Lexington, MA