Director of Quality & Compliance, Global Regulatory Affairs and Clinical Safety

Business Process Owner

This role is designated as the Business Process Owner for Issue Management, Risk Management, and Quality Plan processes. The Q&C organization now functions under a matrix model, allowing all roles to execute processes within the QMS framework. Key responsibilities include participation in Health Authority Inspections, oversight of the Issue Management Processincluding execution and completion of corrective and preventive actions (CAPA)as well as involvement in Knowledge Management, Continuous Improvement initiatives, Risk Management Plans, evaluation of Risk Acceptances, and management of O.P.S. Issues when necessary. Additionally, the position leads Communities of Practice for individuals outside O.P.S. who implement QMS procedures governed by this role. Strategic duties involve providing proactive assessments of compliance culture and governance through input to the GRACS Compliance Council. This role also supports GRACS within Research & Development Division Risk Working Group for holistic risk management at both Research & Development Division and Enterprise levels. The position supervises two Associate Directors.

Primary activities include but are not limited to :

• Serve as Global Process Owner for one or more of the QMS processes managed under GRACS (Global Regulatory Affairs & Clinical Safety) Quality & Compliance.
• Establishes and maintains an engaged Community of Practice (CoP) as well as collaborative, and innovative culture in GRACS for business process management and continuous improvement.
• Partners with Business System Owners on Alignment of Process & Technology.
• Drives accountability for consistent processes execution throughout GRACS.
• Manages and reports process performance against metric targets. Independently supports departmental operational activities utilizing advanced competencies, knowledge and judgment; proactively identifies and resolves complex issues using experience with guidance and support from the GRACS leadership team and colleagues within and external to GRACS, as needed. Serves as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge.
• Applies capabilities to enhance quality and builds capabilities of less experienced staff, as appropriate.
• Manage personnel or assist with the management of personnel and planning functional group activities to achieve functional area and / or departmental objectives.
• Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Good Regulatory Practice, Good Pharmacovigilance Practice, Good Clinical Practice), safety guidelines and company policies and procedures.
• May assist with the preparation or review of relevant SOPs or policies relevant to GRACS or partnering Research & Development Division, Global Human Health or Manufacturing Division organizations. Collaborates effectively across areas within GRACS and partnering organizations to achieve quality goals and understanding of and application of appropriate regulations in partnering with Research & Development Division area.
• May develop, contribute to, or lead educational and training materials and sessions to further develop competencies or process understanding across GRACS and partnering with Research & Development Division, Manufacturing Division, Human Health areas, where applicable.

Primary skills include but are not limited to :

Education / Experience : BS / BA degree in relevant area with extensive experience in quality / compliance.