Mgr Prod Surveillance

Gurgaon, Haryana
Permanent
Full-time

1 day ago

This is where your work makes a difference.At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.Here, you will find more than just a job—you will find purpose and pride.Summary:This role is responsible for managing the Product Surveillance team responsible for end to end complaint processing across various products, following the applicable regulations and procedures. This role oversees and is responsible for the team’s activities and KPI’s. This role demonstrates effectiveness in managing and leading people, decision-making, empowerment of others, problem solving, and task completions for self and others. A strong understanding of FDA, ISO and Baxter Quality systems is also required.Essential Duties and Responsibilities:

Serves as a Subject Matter Expert for PostMarket surveillance processes
Managing team, including mentoring, coaching, development, performance management and staffing decisions; and supervising employees to ensure achievement of operational goals and KPIs, and to ensure team adherence to established processes and regulations
Managing daily work assignments for the team for activities related to complaint processing, to ensure on time complaint processing, regulatory reportability determination, and reporting
Managing key performance indicators for the team, including creating and/or analyzing operations metrics and reports to identify improvement opportunities
Overseeing and providing regular updates and reports on team performance and key metrics to management
Participating in resolution of escalated issues. Identifying and escalating issues as appropriate; ensuring Postmarket Surveillance leadership is informed of high risk issues in a timely manner
Leading and/or participating in cross functional activities and projects, including NCRs/CAPAs
Participating and/or leading audit readiness activities and efforts for Postmarket Surveillance function, including potential risk identification, mitigations, and improvements
Participating in external and internal Audits as a complaint process Subject Matter Expert, including direct interactions with the Auditor(s), providing support to Audit requests, providing support to responses, and driving completion of Audit commitments, as needed
Maintaining a high level of expertise in current regulatory requirements
Reviewing, and revising written Procedures and submitting procedural changes as needed
May perform other Postmarket Product Surveillance activities as assigned

Qualifications:

Ability to effectively communicate (verbal and written) across different functions and across multiple levels within the organization
Ability to effectively manage and lead people and encourage teamwork
Ability to motivate, develop and influence others
Strong understanding of complaint process and regulatory reporting processes, including FDA regulations applicable to Baxter products (medical devices, pharmaceuticals, etc.)
Strong critical thinking and problem solving skills
Ability to drive decisions and actions quickly and effectively
Ability to make independent decisions
Understanding of scientific strategies and ability to invent new methods or new avenues of analyzing large data
Ability to deal with ambiguity
Collaboration and Teamwork
Detail Oriented
Customer Focus
Strong technical writing skills

Education and/or Experience:

Bachelor’s degree (science or engineering preferred) with 5+ years experience in Quality, Manufacturing, Engineering, or a related field.

Experience should include 1-2 years of supervisory responsibility, or 7 years relevant experience in Product Surveillance.

Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

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