Senior Manager, Third Party Manufacturing

Abbott

10-12 years

$127,300 – $254,700 annually

Buffalo Grove

10 June 20, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Manager, Third Party Manufacturing – Abbott, Buffalo Grove, IL

Job Summary:
Abbott is hiring a Senior Manager, Third Party Manufacturing to lead global supplier quality and ensure regulatory compliance within the Medical Devices division in Buffalo Grove, Illinois. This role demands strategic oversight of third-party manufacturing sites and suppliers, focusing on quality systems, audits, risk management, and continuous improvement initiatives, aligned with FDA, ISO 13485, and cGMP standards.

Key Responsibilities:

Lead and implement supplier quality strategy for Third Party Manufacturing (TPM), OEMs, and service providers.
Ensure regulatory compliance with FDA 21 CFR 820 (QSR), ISO 13485, and other international standards.
Manage supplier quality audits, qualification, incident resolution, and performance metrics.
Develop and enforce robust Quality Management Systems (QMS) for TPMs.
Oversee CAPA processes, audit readiness, and quality improvement projects.
Provide strategic leadership to cross-functional teams and TPMs to ensure adherence to product quality requirements.
Support product development, external inspections, and quality system initiatives.
Manage divisional budgets, resources, and staff development related to quality systems.
Act as Quality Systems representative for divisional and global projects.

Required Skills & Qualifications:

Bachelor’s Degree in Engineering or related field (Master’s preferred).
10–12 years’ experience in the Medical Device industry.
4–6 years in a Quality role within the Medical Device sector.
In-depth knowledge of FDA 21 CFR 820, ISO 13485, cGMP, and relevant US regulations.
Strong leadership, cross-functional team management, and decision-making skills.
Proven ability in quality auditing, CAPA management, and risk assessment.

Perks & Benefits:

Base salary range: $127,300 – $254,700 annually.
Free medical coverage via Health Investment Plan (HIP) PPO.
High employer contribution retirement savings plan.
Tuition reimbursement and Freedom 2 Save student debt program.
Global career development opportunities.
Recognized as one of the best companies to work for diversity, working mothers, and women in science.

Company Description:

Abbott is a global healthcare leader delivering innovative medical devices, diagnostics, nutritionals, and branded generic medicines. With 114,000 colleagues across 160+ countries, Abbott is committed to improving lives through technology-driven healthcare solutions.

Work Mode:
On-site (Buffalo Grove, Illinois, USA)

Call to Action:

Ready to lead supplier quality operations at a global healthcare innovator? [Apply Now] to join Abbott’s world-class team in Buffalo Grove, IL, and advance your career in medical device quality management.

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Senior Manager, Third Party Manufacturing

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