Senior Manager - Quality Compliance at Abbott

North Chicago, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Strategic and experienced in leading global internal audit and compliance programs across multiple divisions and sites
Expertise in ensuring adherence to external laws, regulations, guidance, and standards (LRGs)
Ability to drive continuous improvement in quality systems, regulatory compliance, and operational excellence
Experience leading a team responsible for internal audits, investigations, audit execution, and quality system enhancements
Capability to mitigate risk, support external audits, and foster a culture of compliance and performance
Skilled in making critical technical decisions impacting product quality and business continuity
Experience in objective-oriented assignments reviewed on alignment with organizational goals and timelines

Responsibilities

Lead and manage the Divisional Global Quality and Compliance internal audit team, ensuring timely and thorough planning, execution, and closure of audit activities
Oversee internal audits and provide business support to external audits across multiple sites and geographies
Establish, implement, and maintain the effectiveness of the quality system, including the quality policy, quality plan, and supporting organizational structure
Provide strategic direction and long-term planning to meet divisional and site quality goals
Coordinate and lead a broad, multi-disciplinary work unit across multiple sites and product families
Ensure achievement of compliance, financial, and performance goals for large-scale, strategic projects and QA initiatives
Develop and enforce operating policies and procedures that align with company-wide standards and regulatory requirements
Monitor and adjust departmental budgets, schedules, and performance metrics to meet organizational objectives
Evaluate investigation findings and ensure documentation meets “Right First-Time” standards for senior management review
Represent Abbott in interactions with regulatory bodies and standards organizations
Foster a diverse, inclusive, and high-performing team culture through coaching, mentoring, and talent development
Ensure executive management is informed of compliance risks and regulatory requirements

Skills

Quality Systems

Internal Audit

Regulatory Compliance

Investigations

Audit Execution

Quality Management

Compliance Programs

Operational Excellence

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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