Associate Director - Value & Implementation Quality and Standards

Job Description

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.

• 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.

Works 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.

• 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.

• 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…