JOB DESCRIPTION:

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 companys 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

• Bachelors 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.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: