Senior Manager, Global Patient Safety Business Excellence

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead initiatives aimed at enhancing business excellence within Global Patient Safety (GPS).

• Provide strategic leadership in project management, organizational change management, governance, compliance oversight, and enhancing operational effectiveness.

• Collaborate with GPS and key cross-functional stakeholders to ensure the successful execution of vital business initiatives, improve inspection readiness, and foster a culture of continuous improvement.

• Oversee the creation, implementation, and ongoing enhancement of project management and change management standards, methodologies, and best practices throughout GPS.

• Establish and maintain GPS governance frameworks, ensuring effective oversight, decision-making, and alignment with the organization's objectives.

• Direct and execute critical business initiatives within Global Patient Safety and serve as a representative of GPS in enterprise-wide cross-functional programs.

• Offer strategic guidance and oversight for pharmacovigilance activities associated with mergers, acquisitions, licensing agreements, and divestitures.

• Contribute to the improvement and effectiveness of the GPS Quality Management System, ensuring adherence to global regulatory standards.

• Perform tasks assigned by the QPPV as outlined in the PV System Master File and uphold a state of readiness for inspections.

• Assist with Health Authority Inspections, Business Partner audits, and Internal Process Audits relevant to the role, including logistics and operational support.

• Develop, track, and report on key performance and compliance metrics to aid management review, strategic decision-making, and ongoing improvement.

• Facilitate the management of deviations, CAPAs, and quality improvement initiatives across functions to ensure sustainable compliance outcomes.

• Build and nurture strong relationships with internal and external stakeholders, influencing decisions and promoting alignment across complex organizational initiatives.

• Advocate for digital transformation opportunities, including the integration of automation, analytics, and emerging technologies to enhance Global Patient Safety.

⛳️ Requirements

• Doctorate degree & 2 years of Safety Project Management experience OR Master’s degree & 4 years of Safety Project Management experience OR Bachelor’s degree & 6 years of Safety Project Management experience OR Associate’s degree & 10 years of Safety Project Management experience OR High school diploma / GED & 12 years of Safety Project Management experience.

• Proven expertise in project management, change management, and organizational transformation.

• Strong leadership abilities with the capacity to influence others without formal authority.

• Capable of understanding pharmacovigilance regulations and compliance practices, with the ability to distill multiple requirements into clear, concise instructions.

• Demonstrated success working in international settings and with cross-functional teams, exhibiting strong interpersonal skills, assertiveness, team spirit, and coaching abilities.

• Excellent critical thinking and decision-making skills; comfortable with ambiguity and able to work independently when necessary.

• Proficient in managing time and priorities effectively, handling multiple priorities simultaneously.

• Demonstrated capability to utilize digital technologies, automation, and data-driven insights to enhance operational effectiveness and business outcomes.

• Strong facilitation skills, both virtually and in person, including experience engaging with executive leadership.

• PMP certification or an equivalent credential in Change or Project Management.

• Proven track record of successful project execution in regulatory or safety environments.

• Experience with mergers, acquisitions, and divestitures in the Life Sciences sector.

• Substantial leadership experience, particularly with fully remote teams across different time zones.

• Significant background in pharmacovigilance, drug safety, regulatory affairs, quality, or related life sciences functions.

• Established experience in developing governance frameworks and leading complex, enterprise-wide initiatives.

• Experience in presenting to and influencing senior leadership and executive stakeholders.

• Strong analytical skills with the ability to convert data into actionable business insights.

• Experience leading process improvement initiatives utilizing Lean, Six Sigma, Agile, or similar methodologies.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance, along with flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.