Merck Sharp & Dohme
Director of Quality & Compliance, Global Regulatory Affairs and Clinical Safety
Merck Sharp & Dohme, Rahway, New Jersey, us, 07065
Overview
This role is designated as the Business Process Owner for Issue Management, Risk Management, and Quality Plan processes within the QMS framework. The Q&C organization operates in a matrix model allowing all roles to execute processes. The position participates in Health Authority Inspections, oversees the Issue Management Process including execution and completion of corrective and preventive actions (CAPA), and is involved in Knowledge Management and Continuous Improvement initiatives. It also contributes to Risk Management Plans, evaluates risk acceptances, and manages OPS issues when necessary. The role leads Communities of Practice for individuals outside OPS who implement QMS procedures governed by this role. Strategic duties include proactive assessments of compliance culture and governance through input to the GRACS Compliance Council. The role supports GRACS within the Research & Development Division Risk Working Group for holistic risk management at both R&D and Enterprise levels. The position supervises two Associate Directors. Primary activities
Serve as Global Process Owner for one or more of the QMS processes managed under GRACS (Global Regulatory Affairs & Clinical Safety) Quality & Compliance. Establish and maintain an engaged Community of Practice (CoP) and a collaborative, innovative culture in GRACS for business process management and continuous improvement. Partner with Business System Owners on alignment of process & technology. Drive accountability for consistent process execution throughout GRACS. Manage and report process performance against metric targets. Independently support departmental operational activities utilizing advanced competencies, knowledge, and judgment; proactively identify and resolve complex issues with guidance and support from GRACS leadership and colleagues. Serve as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge. Apply capabilities to enhance quality and develop the capabilities of less experienced staff as appropriate. Manage personnel or assist with the management of personnel and planning of functional group activities to achieve objectives. Conduct work in accordance with SOPs, applicable regulations (e.g., GxP), safety guidelines, and company policies and procedures. Assist with the preparation or review of SOPs or policies relevant to GRACS or partnering with R&D, Global Human Health, or Manufacturing divisions. Collaborate across GRACS and partner areas to achieve quality goals and regulatory understanding. Develop, contribute to, or lead educational and training materials and sessions to develop competencies or process understanding across GRACS and partnering areas. Primary skills
Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others to accomplish quality goals; possesses advanced leadership skills. Communication Skills: Demonstrates advanced oral and written communication skills. Problem Solving: Demonstrates expert problem-solving skills using data and stakeholder input to influence organizational direction. Strategic Thinking: Drives change to enhance processes within GRACS and related divisions to improve quality and add value. Project Management: Organizes work, prioritizes tasks, and utilizes resources to deliver or support work products on schedule and in compliance. Decision Making: Uses knowledge networks and data to make rapid, appropriate decisions and escalates when needed. Regulatory and Compliance Management: Knowledge of regulations and trends to ensure GRACS compliance and proactive risk management. Education and Experience
BS/BA degree in a relevant area with extensive experience in quality and compliance. Other
Travel Requirements: 10% Equal Employment Opportunity
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other legally protected status. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. EEO laws, visit the EEOC Know Your Rights page and the EEOC GINA Supplement. We are a company that embraces diversity and inclusion and encourage colleagues to respectfully challenge one another’s thinking and approach problems collectively. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will follow a hybrid model with three on-site days per week (Monday-Thursday) and Friday remote, unless business needs require otherwise. This model does not apply to remote-designated roles or certain on-site roles. Salary: $169,700.00 - $267,200.00. Eligible for annual bonus and long-term incentives where applicable. Benefits include medical, dental, vision, retirement plans, paid holidays, vacation, and sick days. San Francisco and Los Angeles residents: We comply with local fair hiring laws. See local ordinances for details. This posting is active until the stated end date; apply before the end date. Additional information
Regulatory and compliance details, travel, relocation, visa sponsorship, and other employment information are provided in the posting. Current employees or contingent workers may apply where indicated.
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This role is designated as the Business Process Owner for Issue Management, Risk Management, and Quality Plan processes within the QMS framework. The Q&C organization operates in a matrix model allowing all roles to execute processes. The position participates in Health Authority Inspections, oversees the Issue Management Process including execution and completion of corrective and preventive actions (CAPA), and is involved in Knowledge Management and Continuous Improvement initiatives. It also contributes to Risk Management Plans, evaluates risk acceptances, and manages OPS issues when necessary. The role leads Communities of Practice for individuals outside OPS who implement QMS procedures governed by this role. Strategic duties include proactive assessments of compliance culture and governance through input to the GRACS Compliance Council. The role supports GRACS within the Research & Development Division Risk Working Group for holistic risk management at both R&D and Enterprise levels. The position supervises two Associate Directors. Primary activities
Serve as Global Process Owner for one or more of the QMS processes managed under GRACS (Global Regulatory Affairs & Clinical Safety) Quality & Compliance. Establish and maintain an engaged Community of Practice (CoP) and a collaborative, innovative culture in GRACS for business process management and continuous improvement. Partner with Business System Owners on alignment of process & technology. Drive accountability for consistent process execution throughout GRACS. Manage and report process performance against metric targets. Independently support departmental operational activities utilizing advanced competencies, knowledge, and judgment; proactively identify and resolve complex issues with guidance and support from GRACS leadership and colleagues. Serve as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge. Apply capabilities to enhance quality and develop the capabilities of less experienced staff as appropriate. Manage personnel or assist with the management of personnel and planning of functional group activities to achieve objectives. Conduct work in accordance with SOPs, applicable regulations (e.g., GxP), safety guidelines, and company policies and procedures. Assist with the preparation or review of SOPs or policies relevant to GRACS or partnering with R&D, Global Human Health, or Manufacturing divisions. Collaborate across GRACS and partner areas to achieve quality goals and regulatory understanding. Develop, contribute to, or lead educational and training materials and sessions to develop competencies or process understanding across GRACS and partnering areas. Primary skills
Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others to accomplish quality goals; possesses advanced leadership skills. Communication Skills: Demonstrates advanced oral and written communication skills. Problem Solving: Demonstrates expert problem-solving skills using data and stakeholder input to influence organizational direction. Strategic Thinking: Drives change to enhance processes within GRACS and related divisions to improve quality and add value. Project Management: Organizes work, prioritizes tasks, and utilizes resources to deliver or support work products on schedule and in compliance. Decision Making: Uses knowledge networks and data to make rapid, appropriate decisions and escalates when needed. Regulatory and Compliance Management: Knowledge of regulations and trends to ensure GRACS compliance and proactive risk management. Education and Experience
BS/BA degree in a relevant area with extensive experience in quality and compliance. Other
Travel Requirements: 10% Equal Employment Opportunity
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other legally protected status. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. EEO laws, visit the EEOC Know Your Rights page and the EEOC GINA Supplement. We are a company that embraces diversity and inclusion and encourage colleagues to respectfully challenge one another’s thinking and approach problems collectively. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will follow a hybrid model with three on-site days per week (Monday-Thursday) and Friday remote, unless business needs require otherwise. This model does not apply to remote-designated roles or certain on-site roles. Salary: $169,700.00 - $267,200.00. Eligible for annual bonus and long-term incentives where applicable. Benefits include medical, dental, vision, retirement plans, paid holidays, vacation, and sick days. San Francisco and Los Angeles residents: We comply with local fair hiring laws. See local ordinances for details. This posting is active until the stated end date; apply before the end date. Additional information
Regulatory and compliance details, travel, relocation, visa sponsorship, and other employment information are provided in the posting. Current employees or contingent workers may apply where indicated.
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