Senior Manager, Service Compliance
AbbottAbout the role
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of .
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
Our location in Des Plaines, IL, (On-Site) has an opening for the Senior Manager, Service Performance. The person hired in this role will be responsible for the Global Service documentation compliance & governance, in addition to supporting all related audits, CAPA activities, and driving an effective and result oriented organization.
What You’ll Work On
Responsible for the Global Service Documentation Compliance & Governance:
- Enforces all documentation standards, policies, and operating procedure requirements
- Ensures the Service & Support organization follows regulatory and quality processes when performing service functions, as well as drive best in class practices of ticket documentation
- Collaboration with Technical Operations to ensure processes and procedures are in place and followed to properly manage service documentation change control
- Provide global field action service implementation tracking for the Service Organization
Supports all related Audit & CAPA activities
- Lead efforts to prepare for internal & external audit related to servicing teams and processes and serve as primary audit Service contact
- Ensures overall inspection readiness activities for affiliates, FSEs, and Service personnel.
- Represent the Global Service Organization in Service CAPAs
- Project manager Service assigned CAPAs effectively, while meeting each milestone deadline.
Drives an effective and result oriented organization
- Strong leadership skills with demonstrated ability to create momentum and deliver excellent results.
- Strong organization, speaking skills, and influential management ability
- Ability to work effectively within a fast-paced, highly matrixed, and geographically diverse business environment
- Ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
- Provide diligent and fact-based verbal and written communication to Executive Management team, peers and team
- Be a champion of Quality, Lean and disciplined problem solving throughout service organization and cross-collaboration with other departments
- Provide management and development of the Global Service Performance staff
Required Qualifications
- Bachelor's degree or equivalent experience in engineering, life sciences, clinical laboratory science or related discipline.
- Experience in Medical Device industry or other FDA regulated industry experience.
- Minimum 3 years of diverse technical and organizational management experience.
- 5 years of experience in general area of skillset
- Minimum 2 years Quality and/or regulatory experience with exposure to CAPA, complaints investigation, and field actions are preferred.
- Data Analysis experience required.
- Incumbent in this role will conduct Active Monitoring
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