Associate Director – Value & Implementation Quality and Standards

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Lead initiatives aimed at developing, maintaining, reviewing, and providing training on Standards.

• Collaborate with regional leaders to connect global and local Standards.

• Conduct quality and compliance functional monitoring.

• Align V&I Standards with divisional standards and the Quality Management System.

• Assist and engage in audits, assessments, inspections, and privacy initiatives.

• Create, oversee, and implement risk minimization strategies.

• Represent the Director of Quality & Standards at the V&I Operations Leadership Team and other relevant meetings.

• Monitor key initiatives across V&I Operations to ensure alignment within the organization.

• Lead large-scale, complex Standards projects that involve both internal and external stakeholders.

• Plan, orchestrate, and implement Standards initiatives utilizing project charters, plans, and risk management strategies.

• Manage project timelines and resource allocation.

• Collaborate with regions and countries to synchronize V&I and local Standards.

• Assist in the development and execution of Standards training in partnership with Knowledge Management.

• Review and update Standards, process maps, forms, templates, guidelines, and supporting documentation.

• Ensure that Standards are periodically reviewed in accordance with divisional SOPs.

• Facilitate continuous improvement of Standards through the V&I QMS methodology.

• Coordinate training for stakeholders and new employees on Standards and controlled documentation.

• Develop metrics for the deployment and training of Standards and establish methods for collection and dissemination.

• Manage reported Quality Issues.

• Provide guidance regarding Audit Readiness.

• Collaborate with the divisional Quality Group to ensure alignment between V&I Standards, policies, and divisional standards and QMS.

• Monitor how business process and regulatory changes impact Standards documentation.

• Advise on operational changes that may affect V&I’s adherence to Standards.

• Act as the V&I point of contact for Regulatory Surveillance.

• Communicate updates on Standards status and progress to V&I GMVC peers and stakeholders.

• Advocate for the value and importance of Quality & Standards within V&I and toward external stakeholders.

• Address inquiries regarding Standards and related risk management.

⛳️ Requirements

• Bachelor’s degree in life sciences, business, or healthcare.

• A minimum of five (5) years of relevant experience.

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

• Exceptional written, verbal, interpersonal communication, and presentation skills.

• Proficient in writing clear and detailed SOPs.

• Skilled in using AI-enabled tools for simplifying, authoring, and maintaining Standards.

• Familiarity with Quality systems.

• Strong personal integrity and adherence to high ethical standards.

• Ability to organize, prioritize, and work effectively in a dynamic and ambiguous environment.

• Detail-oriented approach.

• Experience as a participant in cross-functional, global initiatives within a complex matrix.

• Strong decision-making, problem-solving, and analytical capabilities.

• Capacity to innovate with practical solutions for complex challenges.

• Ability to work autonomously while appropriately escalating risks and issues.

• Experience with regulations and compliance requirements.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Teams).

• Collaborative communication skills.

• Strong decision-making abilities.

• Detail-oriented focus.

• Effective interpersonal communication skills.

• Knowledge of Medical Affairs.

• Familiarity with Medical Knowledge.

• Experience in Outcomes Research.

• Skills in project leadership.

• Competence in project management.

• Ability to manage project resources effectively.

• Proficient in Standard Operating Procedure (SOP) management.

• Eligibility for residency in the US and Puerto Rico is required.

• No visa sponsorship available.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Healthcare benefits including medical, dental, and vision.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave.

• Sick leave.

• Remote work arrangements.