Associate Director - Value & Implementation Quality and Standards

MSD • Rahway, PA

8d • Hybrid

About The Position

The Associate Director Quality and Standards (Q&S) Steward, Value & Implementation (V&I) Operations, Quality & Standards (AD, Q&S), position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research. The AD, Q&S, is a role within V&I Global Medical and Value Capabilities (V&I GMVC) that reports directly to the Director, Quality & Standards Lead. The AD, Q&S, is an integral member of the V&I Operations team serving as a subject-matter expert around Quality and Standards and is held accountable for assisting and driving execution of the V&I Operations vision. The AD, Q&S, participates in several of the following core V&I global initiatives and assumes varying degrees of project leadership: Leading projects to create, maintain, review and train on Standards. Working on projects collaboratively with regional leads with the goal of linking global and local Standards, performing quality and compliance functional monitoring. Aligning V&I Standards into divisional standards (i.e., quality by design). Aligning Standards with divisional Quality Management System (QMS). Supports and participates in audits, as appropriate. Incorporating into their processes the ability to create, monitor and act against risk minimization plans. The AD, Q&S, possesses strong communication and collaboration skills and the ability to execute innovative ways of working within a complex matrix environment.

Requirements

• Bachelor’s degree in life sciences, business, or health care, plus five (5) years of relevant experience.
• Excellent interpersonal communication (written/oral) and presentation skills with ability to communicate simply and directly without ambiguity.
• Must be proficient in writing clear and detailed SOPs to support standardized and efficient business operations.
• Must be proficient 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, with ability to innovate with practical solutions for complex issues.
• Ability to work independently while escalating risks and issues as appropriate.
• Experience working within regulations and compliance requirements.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, MS Teams).

Nice To Haves

• Deep understanding of the compliance requirements, environment, evolution and global nature of Medical Affairs and Outcomes Research is preferred.

Responsibilities

• Understand the mission and vision of V&I as a science-driven and patient-committed organization.
• Attend V&I Operations Leadership Team and other meetings, as appropriate, as delegate for the Director, Quality & Standards Lead.
• Stay current with key initiatives across V&I Operations and exhibit a high degree of collaboration with colleagues to ensure alignment across the broader organization.
• Exhibit deep subject-matter expertise and strong business acumen.
• Lead large-scale, complex projects established to create, maintain, review, and train on Standards that often involve multiple internal and external stakeholders.
• Be accountable for planning, orchestrating and delivering the Standards initiatives.
• Apply project charters, project plans, and risk planning to all Standards initiatives.
• Manage project timelines and resources to produce results within the committed timeframe.
• Collaborate with regions and countries to ensure alignment between V&I and local Standards, as appropriate.
• Support the development of Standards training and align with V&I Knowledge Management to execute.
• Review Standards on a routine basis and revise Standards, process maps, forms, templates, guidelines, and supporting documentation when appropriate to ensure compliance with regulatory requirements.
• Ensure periodic review of Standards per the divisional standard operating procedures (SOP) of SOPs.
• Adhere to the V&I QMS continuous improvement methodology and support efforts to maintain and improve Standards over time.
• Coordinate with the Knowledge Management team and other V&I colleagues to ensure that relevant stakeholders, including new hires, obtain training on the Standards and other controlled documentation.
• Develop relevant metrics associated with Standards deployment and training and put in place the methods for collecting and disseminating those metrics.
• Manage reported Quality Issues.
• Provide guidance to the V&I organization on Audit Readiness.
• Liaise with the divisional Quality Group to ensure that V&I Standards and policies are aligned with divisional standards (i.e., quality by design) and QMS.
• Monitor the impact of any business process or regulatory changes on Standards documentation.
• Serve as a subject-matter expert on the impact of proposed operational changes to V&I’s ability to meet its Standards.
• Serve as V&I point for Regulatory Surveillance.
• Communicate the status and progress of Standards with V&I GMVC peers and engaged stakeholders.
• Communicate the value and importance of Quality & Standards.
• Respond to questions about Standards and the risk management that they represent to our company.
• Support audits, assessments and inspections, as well as privacy initiatives.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Director