Senior Quality Systems Leader - Pharma & Medical Devices

AbbVie Inc.; North Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

Working with R&D, manufacturing, regulatory affairs and other functions, you will implement and maintain high quality standards and lead audits to ensure continued compliance and process improvements.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related technical field.
• 8+ years’ experience in quality assurance or related roles.
• Experience leading cross-functional teams.
• Strong knowledge of QA, Regulatory, Process Sciences, Manufacturing Operations.
• Familiarity with QA systems and GMP for device, biologics, and pharmaceutical products.
• Ability to work independently and with guidance from management.
• Excellent verbal and written communication skills.
• Strong interpersonal skills; able to lead projects of increasing size.

Responsibilities

• Ensure proper integration and support of quality regulations across products.
• Lead project teams in planning, preparation, review and approval of quality documentation.
• Implement and maintain the effectiveness of the quality system for multiple product types.
• Design effective quality systems and processes within cross functional teams.
• Prepare and present data during regulatory audits (FDA, EMA, etc.) and internal audits.
• Coordinate quality system elements, training, and continuous improvement across functions.
• Support new product introduction and design changes for devices and biotech products.
• Interact with partners to develop best practices in quality systems.
• Perform assessments to identify gaps and implement improvements.
• Oversee training and education programs for quality assurance.

Skills

Leadership

Cross-functional teams

Communication skills

Quality assurance

GMP knowledge

Regulatory knowledge

Education

Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering

Job description

Working with R&D, manufacturing, regulatory affairs and other functions, you will implement and maintain high quality standards and lead audits to ensure continued compliance and process improvements.