Associate Director of Quality Risk Management (QRM) and Business Continuity Planning
About the Role:
This is a challenging and meaningful position that will transform the lives of patients, and the careers of those who do it. You'll have the opportunity to grow and thrive through uncommon opportunities in scale and scope, alongside high-achieving teams rich in diversity.
Responsibilities:
1. Champion process development, deployment, maintenance, monitoring, and improvement of assigned QRM procedures and methodologies (tools) and BCP procedures.
2. Work with Quality Systems and Compliance partners to lead the stakeholder-oriented incorporation/improvement of QRM principles and appropriate risk-based approaches into the business processes of the Quality Management System enterprise-wide.
3. Provide guidance and support to teams in implementing risk management strategies and business continuity plans.
4. Collaborate closely with cross-functional teams to proactively identify, assess, communicate, and mitigate risks associated with our products, processes, and facilities.
5. Foster a culture of risk awareness, risk-informed decision making, and proactive risk management throughout the organization and increase QRM maturity.
6. Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM and BCP processes.
7. Drive process monitoring/adoption and GxP risk profiles through data collection, analysis, trending, and reporting of QRM dashboards, and follow up on non-compliances, risk trends, and continuous improvement.
8. Monitor and evaluate the effectiveness of QRM and BCP initiatives, and recommend improvements as needed.
9. Prepare and present reports on QRM and BCP activities, trends, and performance metrics to senior management.
10. Work effectively across the GxP Quality Management Systems network, engaging with broader Process Owner network and functional/site SMEs to meet project milestones and continuously improve process adoption and enhancements.
11. Participate/lead regulatory surveillance and Pharma Industry networking/benchmarking initiatives with peers internally and externally to ensure awareness of current regulations/guidance that impact QRM processes and identify/execute procedural enhancements as required.
12. Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
13. Support/lead QRM Community of Practices (CoPs) including sharing best practices, training/coaching, and regular communication of QRM strategies/risk dashboards and process improvements.
14. Serve as the liaison between the Global Quality Unit and the BCP teams during a crisis management situation.
15. Support GPS, R&D, and IT Business Units, together with Site BCP owners, with test exercises to check and improve BCP and crisis management processes; improvements should be made to global GxP BCP processes as applicable.
16. Define the process for managing major disruptions to the GxP business, including how to respond in a risk-based manner (incorporating QRM principles, tools, and processes into the response).
17. Continually improve BMS response to GxP BCP after undergoing a crisis management situation.
18. Accountable for the effective and efficient execution of the BCP process by the Site BCP owners, as well as ensuring full compliance with all internal and external regulatory requirements.
19. Provide leadership, coaching, and training for PLs and COP, including both the technical processes and the behaviors necessary to optimize process execution.
20. Support the testing and roll out of IT systems supporting QRM processes and data analytics.
21. Assist with the preparation and reporting for Enterprise Risk Management.
22. This position requires up to 15% travel.