Associate Director – Value & Implementation Quality and Standards

Job not on LinkedIn

🔥 12 hours ago

🏖️ New Jersey, Pennsylvania – Remote

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💵 $156.9k - $247k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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👻 Ghost score 0%

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Logo of MSD

MSD

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Lead projects to create, maintain, review, and train on Standards • Collaborate with regional leads to link global and local Standards • Perform quality and compliance functional monitoring • Align V&I Standards with divisional standards and Quality Management System • Support and participate in audits, assessments, inspections, and privacy initiatives • Create, monitor, and act on risk minimization plans • Represent the Director, Quality & Standards Lead at V&I Operations Leadership Team and other meetings as appropriate • Track key initiatives across V&I Operations and ensure organizational alignment • Lead large-scale, complex Standards projects involving internal and external stakeholders • Plan, orchestrate, and deliver Standards initiatives using project charters, plans, and risk planning • Manage project timelines and resources • Collaborate with regions and countries to align V&I and local Standards • Support Standards training development and execution with Knowledge Management • Review and revise Standards, process maps, forms, templates, guidelines, and supporting documentation • Ensure periodic review of Standards according to divisional SOPs • Support continuous improvement of Standards through the V&I QMS methodology • Coordinate training for stakeholders and new hires on Standards and controlled documentation • Develop metrics for Standards deployment and training and establish collection and dissemination methods • Manage reported Quality Issues • Provide guidance on Audit Readiness • Liaise with the divisional Quality Group to align V&I Standards and policies with divisional standards and QMS • Monitor the impact of business process and regulatory changes on Standards documentation • Advise on operational changes affecting V&I’s ability to meet Standards • Serve as V&I point for Regulatory Surveillance • Communicate Standards status and progress to V&I GMVC peers and stakeholders • Promote the value and importance of Quality & Standards throughout V&I and to external stakeholders • Respond to questions about Standards and related risk management

🎯 Requirements

• Bachelor’s degree in life sciences, business, or health care • Five (5) years of relevant experience • Deep understanding of compliance requirements, environment, evolution, and global nature of Medical Affairs and Outcomes Research preferred • Excellent written, oral, interpersonal communication, and presentation skills • Proficiency writing clear and detailed SOPs • Proficiency using AI-enabled tools to simplify, author, and maintain Standards • Understanding of Quality systems • Strong personal integrity and high ethical standards • Ability to organize, prioritize, and work effectively in a constantly changing, ambiguous environment • Detail-oriented nature • Experience as a member in cross-functional, global initiatives in a complex matrix • Strong decision-making, problem-solving, and analytical skills • Ability to innovate with practical solutions for complex issues • Ability to work independently while escalating risks and issues appropriately • Experience working within regulations and compliance requirements • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, MS Teams) • Collaborative Communications • Decision Making • Detail-Oriented • Interpersonal Communication • Medical Affairs • Medical Knowledge • Outcomes Research • Project Leadership • Project Management • Project Resource Management • Standard Operating Procedure (SOP) Management • US and Puerto Rico residency eligibility stated • No visa sponsorship

🏖️ Benefits

• Annual bonus • Long-term incentive, if applicable • Medical, dental, and vision healthcare • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate days • Sick days • Remote work arrangement

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