Sr. Manager, Post Market Surveillance

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Position Summary:

McKesson Medical-Surgical is seeking a Senior Manager, Post Market Surveillance (PMS) to lead and evolve the organization's post-market quality strategy, integrating complaint handling, adverse event reporting, and pharmacovigilance activities. This role is responsible for ensuring compliance with applicable regulatory requirements, driving continuous improvement, and providing strategic oversight of post-market data to enhance product safety and customer satisfaction. This role supports multiple verticals within McKesson Medical-Surgical including (but not limited to) private label product portfolio, distribution operations and device servicing business. The ideal candidate will bring a strong background in quality systems, medical device or pharmaceutical regulations, and team leadership. This is a M3 level role with primary location at MMS HQ in Richmond, VA. Internal candidates in other geographies will be considered.

The right candidate is expected to demonstrate the following competencies: embrace digital transformation, diverse and inclusive collaboration, strategic and analytical thinking, adaptability and growth mindset, and clear and impactful communication.

Role Summary:

• Lead the Post Market Surveillance team, including complaint handling and pharmacovigilance functions.
• Develop and implement strategies to ensure compliance with FDA and other global regulatory requirements.
• Serve as the subject matter expert for post-market quality processes and represent the function in cross-functional and executive meetings.
• Oversee intake, investigation, and closure of product complaints in eQMS.
• Ensure timely and thorough root cause analysis and implementation of corrective and preventive actions (CAPAs).
• Monitor and report complaint trends, escalating issues as needed.
• Manage pharmacovigilance activities including adverse event intake, assessment, and regulatory reporting.
• Collaborate with Regulatory Affairs and Medical Affairs to ensure timely and accurate submissions to health authorities.
• Analyze post-market data to identify trends, risks, and opportunities for improvement.
• Prepare and present periodic reports to senior leadership and regulatory bodies.
• Maintain and improve quality system procedures related to post-market surveillance.
• Lead audits and inspections related to post-market activities, serving as the Post Market Surveillance SME for all inspections.
• Drive continuous improvement initiatives across the PMS function.
• Improve the complaint intake process with customer service.

General Responsibilities

• Cultivates and maintains a diverse and inclusive culture, encouraging healthy debate from multiple perspectives
• Collaborate and grow strong relationships with internal and external stakeholders including BU Operations Leaders, Compliance, Sales, Legal and Customer Service teams
• Build and train high performing teams while role modeling I2CARE and ILEAD behaviors.
• Drive operational maturity by identifying automation and self-service capabilities with a focus on enterprise-oriented solutions
• Work well in a high-pressure environment, ensuring that work is completed in an accurate and timely fashion
• Other tasks and responsibilities as assigned and needed by organization

Minimum Job Qualifications (Knowledge, Skills, & Abilities):

• Bachelor's degree required, advanced degree preferred.
• Minimum 10 years of experience in Quality Assurance, with at least 7 years in a leadership role.
• Experience in medical device, pharmaceutical, or combination product industries.
• Strong knowledge of 21 CFR 210, 211, 803, 820, ISO 13485, and global pharmacovigilance regulations.
• FDA audit experience.

Critical Skills

• Embrace Digital Transformation: Demonstrate a strong digital mindset by actively seeking and implementing technological solutions to enhance business processes and drive innovation within the team.
• Diverse and Inclusive Collaboration: Foster a collaborative environment that values diversity and inclusion. Build and sustain positive relationships with stakeholders from varied backgrounds to drive professional growth and organizational success.
• Strategic and Analytical Thinking: Exhibit strong business acumen by staying informed about industry trends and aligning projects with broader organizational goals. Use data-driven insights to make informed decisions and influence positive change.
• Adaptability and Growth Mindset: Show adaptability in the face of change and a willingness to take on challenges. Continuously seek learning opportunities and demonstrate resilience to maintain high performance and support team dynamics.
• Clear and Impactful Communication: Communicate complex information clearly and persuasively across all levels of the organization. Utilize storytelling to effectively convey ideas and drive key initiatives forward.

Working Conditions:

Environment

• Traditional office environment

• Travel up to 25%

Physical Requirements

• Large percent of time performing computer-based work is required

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, pleaseclick here.

Our Base Pay Range for this position

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

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