Associate Director, Quality Systems

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 :

• Bachelors 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 crossfunctional 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 shortterm incentive programs. 

• This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

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