Director, Quality Governance

Vor 2 Tagen

Boudry, Schweiz Bristol-Myers Squibb Vollzeit

**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.

**Position Summary**
The Director, Quality Governance will mainly be responsible for designing, developing, and implementing an effective Quality & Compliance Governance framework across nonclinical, clinical and pharmacovigilance functions that empowers decision-making through data-driven insights, cross-functional collaboration and continuous innovation. Ensuring that key highlights, areas of excellence, and risks are escalated to relevant governance bodies in a proportionate manner, with a focus on significant matters that impact the business.

**Key Responsibilities**
- Responsible to design, develop and implement an effective Q uality and C ompliance G over n ance framework across nonclinical, clinical and pharmacovigilance in partnership with RDQ Leadership Team, Global Quality, D rug D evelopment and Early Research.
- Lead the roll up of relevant R&D risks and insights for reporting to Global Quality Councils, Enterprise Risk Committees, and overall Global Quality Risk Management.
- Operationalize Enterprise QRM strategy in R&D together with the QRM experts across functional units.
- Drive the effective management of R&D Quality Councils across nonclinical, clinical and pharmacovigilance ( final accountability resides with GxP Quality Council Co-Chairs ) ensuring rigor in meeting, action, documentation and timely follow-up on actions and decisions.
- Partner with GCP, GVP and GLP Quality Council Co-Chairs and R&D Quality Leadership Team, to ensure continuous assessment, evaluation, and communication of strategic, compliance, quality and operational risks within R&D.
- Ensure alignment with regulatory requirements, industry standards, and best practices ( e.g. provide oversight to ensur e connectivity in the implementation of new reg ulations ).
- Conduct comprehensive data analysis and interrogation of data to derive meaningful, actionable insights that support data-driven decision-making at Global GxP Quality Councils.
- Ensure that the right conversations occur at the appropriate levels with the relevant stakeholders, focusing on what matters most to the business.
- Partner with Global Quality - Predictive Quality to ensure quality metrics are aligned with organizational goals, regulatory requirements, and support development of tools and reports to drive inspection readiness.
- Partner with Global Quality - Product Quality Management to provide insights on quality, compliance and operational risks to products in clinical trials and post marketing.
- Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.
- Champion a Quality Mindset and ensure compliance with key ICH guidelines ( e.g. E8, E6, E9, Q9 ) and other relevant regulatory requirements.

Other
- Drive continuous improvement initiatives to enhance quality processes and systems.
- Develop and deliver training programs to enhance quality awareness and competencies across the organization.
- Provide leadership, guidance, development and coaching for management of significant quality issues.
- Establish strong partnerships with business stakeholders.
- External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.
- Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.
- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.
- Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline. Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.
- Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to indirect reports/peers within the organization.
- May influence the external environment through interactions with regulators, trade associations, or professional societies.
- Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

**Qualifications & Ex

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