Senior Manager, Global Supplier Quality & Compliance

BioSpace; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) plan

Paid time off

Job summary

AbbVie is seeking a senior professional to lead compliance for worldwide supplier materials and services, ensuring quality and regulatory adherence across medical devices and drug development. This role provides leadership in evaluating external suppliers, implementing Quality Agreements, and guiding R&D on GXP requirements.

You will collaborate across RDQA and other functional areas, drive continuous improvement, and manage metrics for External Partners Quality while upholding AbbVie's

Qualifications

• Bachelor's degree in technical or scientific area or equivalent experience (8+ years) with exposure to medical device or combination product industries.
• Understand international regulatory standards and GxP (GMP, GLP, GCP, GDP, GCLP) and Medical Device regulations.
• Technical background with knowledge of supplier oversight.
• Familiarity with quality/operational systems supporting study/product design and device development.
• Strong communication, leadership, judgment, and organizational skills.
• 8+ years in QA/Regulatory Affairs, healthcare or related fields; ASQ certifications desirable.

Responsibilities

• Oversee supplier compliance programs and conduct evaluations.
• Interpret and apply regulations, policies, and guidelines for activities.
• Lead Quality Agreement lifecycle, reviews, and terminations as needed.
• Act as R&D expert in GXP requirements.
• Collaborate with R&D to resolve external supplier quality issues.
• Prioritize activities to meet study and program objectives.
• Lead or participate in cross-functional, strategic projects.
• Improve regulatory compliance initiatives and standards.
• Balance involvement with independence and objectivity.
• Collect and report metrics on External Partners Quality.
• Demonstrate AbbVie's Ways of Working and leadership; foster learning and innovation.

Education

Bachelor's degree in technical or scientific field (Chemistry, Pharmacy, Biology, Microbiology, or Engineering)

Excellent oral/written communications

Interpersonal skills

Leadership qualities

Persuasive, cross-functional collaboration

Job description

AbbVie is seeking a senior professional to lead compliance for worldwide supplier materials and services, ensuring quality and regulatory adherence across medical devices and drug development. This role provides leadership in evaluating external suppliers, implementing Quality Agreements, and guiding R&D on GXP requirements.

You will collaborate across RDQA and other functional areas, drive continuous improvement, and manage metrics for External Partners Quality while upholding AbbVie's