Merck
Director of Quality & Compliance, Global Regulatory Affairs and Clinical Safety
Merck, North Wales, Pennsylvania, United States
Overview
Director of Quality & Compliance, Global Regulatory Affairs and Clinical Safety. This role is designated as the Business Process Owner for Issue Management, Risk Management, and Quality Plan processes. The Q&C organization operates under a matrix model, enabling all roles to execute processes within the QMS framework. The role supervises two Associate Directors and provides strategic input on compliance culture and governance to GRACS.
The position supports GRACS within our Research & Development Division Risk Working Group for holistic risk management at both the Research & Development Division and Enterprise levels and participates in Health Authority Inspections, CAPA execution, and related quality activities.
Responsibilities
Serve as Global Process Owner for one or more QMS processes managed under GRACS (Global Regulatory Affairs & Clinical Safety) Quality & Compliance.
Establish and maintain an engaged Community of Practice (CoP) and foster a collaborative, innovative culture in GRACS for business process management and continuous improvement.
Partner with Business System Owners to align process and technology; drive accountability for consistent process execution across GRACS.
Manage and report process performance against metric targets; independently support departmental operations using advanced competencies and judgment; act as a Subject Matter Expert 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 and plan functional group activities to achieve objectives; ensure work is conducted in accordance with SOPs, applicable regulations (e.g., GxP), safety guidelines, and company policies.
Assist with the preparation or review of relevant SOPs or policies related to GRACS or partnering organizations; collaborate across GRACS and partnering areas to achieve quality goals and regulatory understanding.
Develop, contribute to, or lead educational and training materials and sessions to advance competencies across GRACS and partnering divisions where applicable.
Qualifications BS/BA degree in a relevant area with extensive experience in quality and compliance.
Skills & Capabilities
Collaboration and Partnering: Advanced ability to work in partnership to achieve quality goals with leadership skills.
Communication: Advanced oral and written communication skills.
Problem Solving: Expert level problem solving with data gathering and stakeholder input to influence direction.
Strategic Thinking: Ability to drive change that improves quality processes and adds business value.
Project Management: Expert ability to organize work, prioritize tasks, and manage resources to meet timelines and regulatory requirements.
Regulatory & Compliance Management: Advanced knowledge of regulations and trends; proactively managing and mitigating risks.
Other Information
Location/Residence: US and Puerto Rico; San Francisco and Los Angeles local notices where applicable; Hybrid work model in the US (three days on-site per week, Friday remote, subject to business needs).
Salary range: $169,700.00 - $267,200.00. Salary is based on education, experience, location, and business needs.
Benefits include medical, dental, vision, retirement (401(k)), paid holidays and leave. More information at the company compensation and benefits page.
Apply at the Merck careers site. Application deadlines are specified on the posting.
Equal Employment Opportunity statements and accommodations information are included in the posting.
Travel: 10%; Visa sponsorship: No; Relocation: No.
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Research Services
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The position supports GRACS within our Research & Development Division Risk Working Group for holistic risk management at both the Research & Development Division and Enterprise levels and participates in Health Authority Inspections, CAPA execution, and related quality activities.
Responsibilities
Serve as Global Process Owner for one or more QMS processes managed under GRACS (Global Regulatory Affairs & Clinical Safety) Quality & Compliance.
Establish and maintain an engaged Community of Practice (CoP) and foster a collaborative, innovative culture in GRACS for business process management and continuous improvement.
Partner with Business System Owners to align process and technology; drive accountability for consistent process execution across GRACS.
Manage and report process performance against metric targets; independently support departmental operations using advanced competencies and judgment; act as a Subject Matter Expert 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 and plan functional group activities to achieve objectives; ensure work is conducted in accordance with SOPs, applicable regulations (e.g., GxP), safety guidelines, and company policies.
Assist with the preparation or review of relevant SOPs or policies related to GRACS or partnering organizations; collaborate across GRACS and partnering areas to achieve quality goals and regulatory understanding.
Develop, contribute to, or lead educational and training materials and sessions to advance competencies across GRACS and partnering divisions where applicable.
Qualifications BS/BA degree in a relevant area with extensive experience in quality and compliance.
Skills & Capabilities
Collaboration and Partnering: Advanced ability to work in partnership to achieve quality goals with leadership skills.
Communication: Advanced oral and written communication skills.
Problem Solving: Expert level problem solving with data gathering and stakeholder input to influence direction.
Strategic Thinking: Ability to drive change that improves quality processes and adds business value.
Project Management: Expert ability to organize work, prioritize tasks, and manage resources to meet timelines and regulatory requirements.
Regulatory & Compliance Management: Advanced knowledge of regulations and trends; proactively managing and mitigating risks.
Other Information
Location/Residence: US and Puerto Rico; San Francisco and Los Angeles local notices where applicable; Hybrid work model in the US (three days on-site per week, Friday remote, subject to business needs).
Salary range: $169,700.00 - $267,200.00. Salary is based on education, experience, location, and business needs.
Benefits include medical, dental, vision, retirement (401(k)), paid holidays and leave. More information at the company compensation and benefits page.
Apply at the Merck careers site. Application deadlines are specified on the posting.
Equal Employment Opportunity statements and accommodations information are included in the posting.
Travel: 10%; Visa sponsorship: No; Relocation: No.
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Research Services
#J-18808-Ljbffr