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Senior Manager, Third Party Manufacturing

10-12 years
$127,300 – $254,700 annually
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.