Job DescriptionThe 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.
Responsibilities and Primary ActivitiesLeadership- Understands the mission and vision of V&I as a science-driven and patient-committed organization.
- Attends V&I Operations Leadership Team and other meetings, as appropriate, as delegate for the Director, Quality & Standards Lead.
- Stays current with key initiatives across V&I Operations and exhibits a high degree of collaboration with colleagues to ensure alignment across the broader organization.
- Exhibits deep subject-matter expertise and strong business acumen.
Quality & StandardsWorks with the Director, Quality & Standards Lead, to lead large-scale, complex projects established to create, maintain, review, and train on Standards that often involve multiple internal and external stakeholders:
- Is accountable for planning, orchestrating and delivering the Standards initiatives.
- Applies project charters, project plans, and risk planning to all Standards initiatives.
- Manages project timelines and resources to produce results within the committed timeframe.
- Collaborates with regions and countries to ensure alignment between V&I and local Standards, as appropriate.
- Supports the development of Standards training and aligns with V&I Knowledge Management to execute.
- Reviews Standards on a routine basis and revises Standards, process maps, forms, templates, guidelines, and supporting documentation when appropriate to ensure compliance with regulatory requirements.
- Ensures periodic review of Standards per the divisional standard operating procedures (SOP) of SOPs.
- Adheres to the V&I QMS continuous improvement methodology and supports efforts to maintain and improve Standards over time.
- Coordinates 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.
- Develops relevant metrics associated with Standards deployment and training and puts in place the methods for collecting and disseminating those metrics.
- Manages reported Quality Issues.
- Provides guidance to the V&I organization on Audit Readiness.
Aligns current and planned Standards with the divisional Quality Group and V&I Compliance:
- Liaises 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.
- Monitors the impact of any business process or regulatory changes on Standards documentation.
- Serves as a subject-matter expert on the impact of proposed operational changes to V&I's ability to meet its Standards.
- Serves as V&I point for Regulatory Surveillance.
- Communicates the status and progress of Standards with V&I GMVC peers and engaged stakeholders.
- Serves as an ambassador for Quality & Standards throughout V&I and to external stakeholders as needed:
- Communicates the value and importance of Quality & Standards.
- Responds to questions about Standards and the risk management that they represent to our company.
- Supports audits, assessments and inspections, as well as privacy initiatives.
Required Qualifications, Skills and Experience- Bachelor's degree in life sciences, business, or health care, plus five (5) years of relevant experience.
- Deep understanding of the compliance requirements, environment, evolution and global nature of Medical Affairs and Outcomes Research is preferred.
- 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).
Required Skills: 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
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status: Regular
Relocation:No relocation
VISA Sponsorship:No
Travel Requirements:10%
Flexible Work Arrangements:Hybrid
Shift:Not Indicated
Valid Driving License:No
Hazardous Material(s):n/a
Job Posting End Date:08/18/2026
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