Associate Director, Quality Systems
AbbVie
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose
This position defines, implements, and monitors the performance of the systems related to quality assurance. Additionally, this role provides oversight to the supplier quality and quality engineering programs.
Responsibilities
- Interface with Operations QA; Site QA leadership/QPs, Centers of Excellence, Product Quality to ensure connection and providing direction and leveraging affiliate QA knowledge for process improvements.
- Prepare and present data during regulatory audits and internal audits. Lead quality system elements, training, continuous improvement, and tactical support across functions and global affiliate entities.
- Responsible for initiation, selection, coordination, and management of quality system projects. Lead project teams and/or direct staff in planning, preparation, review and approval of quality documentation.
- Interact with internal and external partners for development of best practices in our quality systems and procedures applicable to affiliate operational complexity and regulatory complexity across the global affiliate enterprise.
- Ensures all product, process or system related quality activities at the Affiliate are following Corporate, governmental, and local regulations.
- Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
- Manage a team of quality professionals across the regions, setting performance expectations, providing feedback, development of staff and handling of personnel situations. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs.
Qualifications
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area.
- 10+ years’ experience in quality assurance, quality oversight or relevant experience.
- Proven managerial leadership of technical professionals and/or in leading cross-functional teams.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
- Experience working and/or managing in both team setting and independently. Works well with minimal manager guidance while able to manage own time and/or teams effectively.
- Strong oral (with all levels of management) and written communication skills needed.
- Excellent interpersonal skills a plus.
- Can create strategic plans integrated into the overall quality system to deliver large and complex programs or projects.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html