Associate Director, Device Quality - Combination Products

North Chicago, IL, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Are you a quality-driven leader with extensive experience in the pharmaceutical industry? Do you have a passion for ensuring the safety and efficacy of combination products? If so, AbbVie has an exciting opportunity for you as an Associate Director of Device Quality for Combination Products. In this role, you will play a vital role in overseeing the quality of our combination products and ensuring compliance with rigorous regulations. We are seeking a highly motivated and experienced individual with a strong attention to detail and a proven track record of success in quality management. If you are ready to take the next step in your career and make a significant impact on patient health, we encourage you to apply.

Develop and implement quality management plans and systems to ensure compliance with regulatory requirements for combination products.
Oversee and manage all aspects of quality for combination products, including design, development, manufacturing, and post-market surveillance.
Lead and mentor a team of quality professionals to ensure consistent and high-quality standards are met.
Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory, to ensure quality standards are met at all stages of product development.
Develop and maintain relationships with external partners and vendors to ensure the quality of components and materials used in combination products.
Conduct risk assessments and implement risk management strategies to mitigate potential quality issues.
Monitor and analyze quality data to identify trends and implement corrective and preventive actions as needed.
Stay informed on industry trends, regulations, and best practices related to combination products and incorporate into quality management processes.
Represent the company in interactions with regulatory agencies and participate in inspections and audits.
Continuously evaluate and improve the quality management system to drive efficiency and effectiveness.
Communicate quality-related issues and updates to senior management and other stakeholders.
Ensure timely and accurate reporting of quality metrics and compliance status to relevant parties.
Develop and manage budgets for quality-related activities and initiatives.
Uphold a culture of quality and compliance within the organization, promoting a patient-centric mindset.
Serve as a subject matter expert on combination product quality and provide guidance and support to other departments as needed.

Where is this job?

This job is located at North Chicago, IL, USA

Job Qualifications

In-Depth Knowledge Of Fda And Global Regulatory Requirements For Combination Products, Including Drug Delivery Devices, Biologics, And Pharmaceuticals.
Minimum Of 8 Years Of Experience In Quality Assurance And Compliance Within The Pharmaceutical Or Medical Device Industry, With A Focus On Combination Products.
Strong Understanding Of Current Good Manufacturing Practices (Cgmp) And Quality System Regulations (Qsr) For Medical Devices, As Well As Iso 13485 And Iso 14971 Standards.
Proven Experience In Leading And Managing Quality Teams, With A Demonstrated Ability To Develop And Implement Quality Systems And Processes.
Excellent Communication And Interpersonal Skills, With The Ability To Collaborate Effectively With Cross-Functional Teams And External Partners.

Required Skills

Risk Management
Quality Assurance
Process Improvement
Project Management
Data Analysis
Team Management
Leadership
Technical Writing
Root Cause Analysis
Audit management
Regulatory compliance
Supplier management

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Associate Director, Device Quality - Combination Products in North Chicago, IL, USA is $140,000 - $170,000 per year. This may vary depending on factors such as the company, years of experience, and specific job responsibilities.

Additional Information

AbbVie is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedFebruary 6th, 2025

Apply BeforeJune 21st, 2025

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