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. 

Responsibilities and Primary Activities

Leadership

• 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 & Standards

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.

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:

• Communic