Compliance Operations Sr. Specialist
Abbott
**Position Summary**
Global Business Services (GBS) within the Abbott Rapid and Molecular Diagnostics Division (RMDx) has a global accountability to deliver an exceptional customer experience and create business value through compliance, standardization, and data analytics. GBS fosters a collaborative, team-focused and winning environment where employees are accountable and encouraged to develop themselves.
The **RDNA Compliance Operations Sr. Specialist** is responsible for ensuring operational excellence through adherence to regulatory and internal policy standards. This position supports the strategic development and execution of compliance programs, partnering across functions to mitigate risk, drive continuous improvement, and uphold the integrity of RDNA operations. The role is embedded within Global Business Services (GBS), which is committed to delivering exceptional customer experiences and business value through compliance, standardization, and data analytics.
**Essential Duties and Responsibilities (Key Activities)**
+ Carries out duties in compliance with established business policies and procedures.
+ Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality processes as per ISO, FDA, and other regulatory agencies.
+ Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
+ Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
+ Develop, implement, and update compliance policies and procedures to ensure alignment with quality standards.
+ Maintain accurate records of compliance activities, including audits, training sessions, and incidents of non-compliance.
+ Drives Corrective and Preventive Actions (CAPA) and Quality Improvement (QI) initiatives to resolve compliance gaps and operational performance.
+ Lead and support the preparation and participation in internal and external audits to ensure compliance with regulatory standards. Identify and document best practices, and translate audit insights into actionable improvements to strengthen future audit readiness frameworks.
+ Attend business meetings as needed to provide compliance-related insights, feedback, and guidance that support informed decision-making and regulatory alignment.
+ Perform other duties and tasks as assigned.
**Dimensions – Education/Experience/Skills**
+ **Bachelor's Degree:** Required, along with 2 years of experience in operations, process improvement, or quality. Alternatively, a High School Diploma with 5 years of experience in operations, process improvement, or quality is also acceptable.
+ **Regulatory Knowledge:** Solid understanding of quality compliance objectives and applicable regulatory standards (e.g., ISO, FDA) to ensure operational adherence and risk mitigation.
+ **Analytical Skills:** Ability to evaluate quality systems, policies, and procedural documentation to identify compliance gaps, assess risks, and support continuous improvement initiatives.
+ **Attention to Detail:** Keen eye for detail to ensure accuracy in compliance activities.
+ **Communication Skills:** Strong verbal and written communication abilities to effectively convey compliance requirements, collaborate across departments, and document findings with clarity and precision.
+ **Problem-Solving:** Skilled in identifying root causes of compliance issues and implementing effective solutions that support regulatory adherence and operational excellence.
+ **Organizational Skills:** Ability to manage multiple compliance-related tasks, priorities, and deadlines efficiently while maintaining accuracy and adherence to regulatory standards.
+ **Ethical Judgment:** Strong sense of ethics and integrity to uphold compliance standards.
+ **Interpersonal Skills:** Ability to work collaboratively with different departments and provide guidance on compliance matters.
+ **Technical Proficiency:** Familiarity with QMS Agile system, SAP, or other ERP applications.
+ **Adaptability:** Ability to stay updated with changing regulations and adapt compliance strategies accordingly.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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