The Regeneron Manager QA Auditor-Strategy is a key position in the Quality Assurance and Auditing group and will provide guidance and leadership for the management of the GCP Audit Programs. This individual will create strategic partnerships and direct risk-based audit activites with Global Development departments. The Manager QA Auditor-Strategy provides support and oversight of multiple assigned molecules, clinical studies and audit programs within the GCP Strategy. They are the liaison between the Global Development organization and audit teams. They are responsible for the full life cycle of the molecules to which they are assigned, executing audit risk assessments, developing audit plans, determining audit strategy, supporting auditors and providing metrics reports to study team. Additionally, they will also be responsible for assigned audits; the number and type of audits assigned will be dependent on their workload and audit schedule.
Job duties may include but are not limited to:
- Partner with key stakeholders to develop risk-based audit planning for assigned molecules and studies as well as vendors and processes, as needed.
- Maintain strategic audit plans based on risk indicators from study teams and the development organization.
- Ensure audits are conducted in accordance with the approved audit plans and schedules.
- Maintain relevant core study specific information to assist auditors with audit preparation and conduct.
- Utilize audit outcomes to identify quality related trends and communicate compliance risks to the organization.
- Contribute to the development and lead the implementation of continuous quality improvement initiatives.
- While not a primary role, the strategy group may also schedule, prepare and conduct audits in support of GCP Audit group as needed.
- Assembles and coordinates the activities of the audit team.
- Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations.
- Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.
- Appropriately escalate any compliance issues.
- Manages and supports post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.
- May assist with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
- Drafts and issues periodic reports to QAA and Global Development management as requested.
- Provides education and/or training to GCP functional areas as well serve as a recognized trainer of new QA staff assisting with their orientation.
Assist QAA management with other ad-hoc QAA activities