Associate Director of Quality Risk Management
vor 4 Wochen
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
**Qualifications and Experience**:
- Bachelor's degree in a relevant scientific or technical field. Advanced degree preferred.
- 8+ years of experience within the pharmaceutical or biotechnology industry
- 4+ + years of experience in Quality Risk Management (QRM). within the pharmaceutical or biotechnology industry.
- Experience in Business Continuity Management (BCM) desired
- Strong knowledge of GxP regulations and guidelines.
- Proven experience in driving process optimization, integration, and continuous improvement.
- Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively.
- Strong leadership and project management skills, with the ability to lead cross-functional teams.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
- Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
- Strong attention to detail and a commitment to ensuring the safety, quality, and continuity of operations.
- Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
- Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
**Responsibilities**:
- Champion process development, deployment, maintenance, monitoring and improvement of assigned QRM procedures and methodologies (tools) and BCP procedures.
- 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.
- Provide guidance and support to teams in implementing risk management strategies and business continuity plans.
- Collaborate closely with cross-functional teams to proactively identify, assess, communicate and mitigate risks associated with our products, processes, and facilities.
- Stay updated with industry best practices and regulatory requirements related to QRM and BCP.
- Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this increase QRM maturity.
- Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM and BCP processes.
- Drive process monitoring/adoption and GxP risk profiles through data collection, analysis, trending and reporting of QRM dashboards, and following up on non-compliances, risk trends, and continuous improvement.
- Monitor and evaluate the effectiveness of QRM and BCP initiatives, and recommend improvements as needed.
- Prepare and present reports on QRM and BCP activities, trends, and performance metrics to senior management.
- Work effectively across the GxP Quality Management Systems network, engaging with broader Process Owner network and functional/site SMEs in order meet project milestones, and continuously improvement process adoption and enhancements.
- 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.
- Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
- Lead/support QRM training/certification development & deployment as per QRM training strategy
- Support/lead QRM Community of Practices (CoPs) including sharing best practices, training/coaching and regular communication of QRM strategies/risk dashboards and process improvements.
- Serve as the liaison between the Global Quality Unit and the BCP teams during a crisis management situation.
- 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.
- Define the process for managing major disruptions to the GxP business includi
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