Associate Director - Value & Implementation Quality and Standards

Job description

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: 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 US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $156,900.00 - $247,000.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, ce