The Sr Manager Post-Market Complaint Operations provides robust leadership, strategic oversight, and direction for a global team responsible for vigilance reporting across the globe including US, Canada, and EAME regions. It holds the responsibility of ensuring the health of the Post Market Quality Assurance Complaints quality system in collaboration with peers. This role ensures rigorous compliance with current and evolving regulatory requirements while promoting proactive, high-quality management practices throughout the organization. The incumbent will foster strong partnerships and drive alignment among key stakeholders—including Pharmacovigilance, Regulatory Affairs, Device Quality Assurance, and Product Quality—supporting project goals, audits, and surveillance activities. The role represents the company, along with stakeholders, in regulatory communications, internal and external inspections, and is accountable for maintaining up-to-date knowledge of global regulations.

Responsibilities:

• Lead and inspire the Complaint Reporting team to deliver excellence in all reporting activities, leveraging a strategic and future-oriented mindset.

• Ensure thorough identification, evaluation, and escalation of potentially reportable events, informing relevant functions and senior leadership promptly.

• Collaborate closely with Complaint Operations to proactively monitor complaint trends and ensure seamless transition and coordination between teams.

• Develop and review formal documentation in compliance with GMP standards for regulatory filings and reporting (e.g., Form 3500A, Med Dev).

• Serve as primary liaison with Regulatory Affairs, Pharmacovigilance, Product and Device Quality Assurance, overseeing and facilitating report submissions and continuous communication.

• Manage and/or participate in cross-functional project teams focusing on process improvements, new product launches, and issue resolution, providing expert oversight and guidance.

• Direct specific areas of the reporting process, ensuring efficient operations and high standards for personnel involved in each stage.

• Support leadership by contributing to strategic planning and continuous improvement initiatives, staying abreast of evolving country-specific regulations and external trends.

• Represent the organization confidently during internal and external regulatory audits, inspections, and agency interactions, ensuring ongoing compliance.