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Abbott

Makes heart devices, glucose sensors and lab tests

Technical Program Manager - Quality Systems

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeColumbus, OH, USA$113.3k - $226.7k

About the Job

Requirements

  • A bachelor's degree in Engineering, Food Science, Microbiology, Quality Assurance, Life Sciences, or a related technical discipline is required.
  • At least 10 years of experience in quality systems, quality assurance, manufacturing, engineering, regulatory compliance, or related technical leadership roles is required.
  • Demonstrated expertise in Quality Management Systems, good manufacturing practices, quality risk management, audit programs, corrective and preventive action systems, and regulatory compliance within regulated manufacturing environments is required.
  • Strong knowledge of applicable regulatory requirements and quality standards governing infant formula, nutritional products, food manufacturing, or comparable regulated industries is required.
  • Experience leading complex cross-functional programs and initiatives in a global organization is required.
  • Proven ability to monitor quality system performance, identify risk trends, drive continuous improvement, and implement effective preventive and corrective actions is required.
  • Strong strategic thinking and decision-making skills, with the ability to balance quality, compliance, business, and operational objectives, are required.
  • Demonstrated success influencing stakeholders and obtaining alignment across multiple functions and levels of leadership is required.
  • Analytical, problem-solving, facilitation, and project management skills are required.
  • Experience supporting regulatory inspections, third-party audits, and enterprise-level quality transformation initiatives is required.
  • Verbal and written communication skills to communicate complex technical concepts to diverse audiences, including executive leadership, are required.
  • Ability to work collaboratively in a fast-paced, highly matrixed global environment is required.
  • A self-directed, results-oriented approach and a strong sense of ownership and accountability are required.
  • Knowledge of digital quality systems, data analytics, and quality performance dashboards is required.
  • Ability to travel up to 25% is required.

Responsibilities

  • Lead the planning, development, execution, and continuous improvement of global equipment- and facility-based Quality System programs supporting operational, engineering, quality, and regulatory objectives.
  • Serve as the Quality System subject matter expert and strategic owner for technical Quality Management System subsystems, ensuring their long-term effectiveness, sustainability, performance, and alignment with business objectives and regulatory requirements.
  • Provide technical leadership and guidance to manufacturing sites, quality organizations, engineering teams, and project teams on Quality System requirements and implementation strategies.
  • Act as the document owner for assigned Quality System elements, maintaining policies, procedures, standards, and processes aligned with regulatory expectations and Abbott Quality Requirements.
  • Support global sites in aligning local procedures and practices with enterprise-level quality requirements and expectations.
  • Develop and maintain quality system metrics and reporting tools that provide leadership visibility and support decision-making.
  • Monitor technical Quality System health and performance using data-driven approaches to identify trends, emerging risks, and improvement opportunities before failures occur.
  • Understand business challenges, proactively identify tactical and strategic risks, and develop mitigation plans.
  • Evaluate how regulatory changes, industry trends, and emerging best practices affect assigned Quality Systems, and drive required implementation changes.
  • Consult on resolution of audit observations, investigations, and corrective actions, including evaluating and replicating improvements across the Abbott Nutrition network.
  • Provide Quality System impact assessments and technical recommendations for significant projects, regulatory changes, remediation activities, and business initiatives.
  • Represent Abbott Nutrition with Abbott Quality Requirements, external auditors, industry organizations, and other Abbott divisions as appropriate.
  • Coordinate stakeholder engagement, governance activities, and cross-functional alignment for quality system programs and initiatives.
  • Benchmark internal and external best practices and apply cross-functional and cross-divisional learnings to improve Quality System effectiveness.
  • Build the case for change for technical Quality System elements and support adoption of new processes, technologies, and business practices.
  • Develop and maintain business continuity plans, including training programs, playbooks, and knowledge-transfer resources, to ensure long-term sustainability of assigned systems.
  • Provide leadership, coaching, and mentoring to quality, manufacturing, and engineering personnel across the organization.

Desired Qualifications

  • Relevant technical background or subject matter expertise in the design, commissioning, and validation of buildings, facilities, utilities, equipment, and/or production processes for nutritional products or similar industries is preferred.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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