Compliance Operations Sr. Specialist at Abbott

Taguig City, National Capital Region, Philippines

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical DevicesIndustries

Requirements

Bachelor's Degree with 2 years of experience in operations, process improvement, or quality (or High School Diploma with 5 years of experience in operations, process improvement, or quality)
Solid understanding of quality compliance objectives and applicable regulatory standards (e.g., ISO, FDA)
Analytical skills to evaluate quality systems, policies, and procedural documentation, identify compliance gaps, assess risks, and support continuous improvement
Attention to detail for accuracy in compliance activities
Strong verbal and written communication skills to convey compliance requirements, collaborate across departments, and document findings
Problem-solving skills to identify root causes of compliance issues and implement effective solutions
Organizational skills to manage multiple tasks, priorities, and deadlines while maintaining accuracy and adherence to standards
Strong sense of ethics and integrity to uphold compliance standards
Interpersonal skills to work collaboratively with different departments and provide guidance

Responsibilities

Carry out duties in compliance with established business policies and procedures
Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality processes as per ISO, FDA, and other regulatory agencies
Exhibit professional behavior with internal/external business associates that reflects positively on the company
Understand and maintain awareness of quality consequences from improper performance of job duties
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
Drive Corrective and Preventive Actions (CAPA) and Quality Improvement (QI) initiatives to resolve compliance gaps and operational performance issues
Lead and support preparation and participation in internal and external audits to ensure compliance with regulatory standards; identify and document best practices; translate audit insights into actionable improvements
Attend business meetings to provide compliance-related insights, feedback, and guidance for informed decision-making and regulatory alignment
Perform other duties and tasks as assigned

Skills

Key technologies and capabilities for this role

Regulatory ComplianceISO StandardsFDA RegulationsCAPAAuditsQuality ManagementCompliance PoliciesCorrective ActionsPreventive ActionsData Analytics

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A Bachelor's Degree is required along with 2 years of experience in operations, process improvement, or quality; alternatively, a High School Diploma with 5 years of experience in those areas is acceptable. A solid understanding of quality compliance objectives and regulatory standards like ISO and FDA is also needed.

What are the main responsibilities of the Compliance Operations Sr. Specialist?

The role involves developing and updating compliance policies, maintaining records of compliance activities, driving CAPA and QI initiatives, leading audits, and providing compliance insights in meetings.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or what is the location policy?

This information is not specified in the job description.

What is the company culture like at Abbott's Global Business Services?

GBS fosters a collaborative, team-focused, and winning environment where employees are accountable and encouraged to develop themselves.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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