Job Details

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 (https://www.tiktok.com/@abbvie) .

Job Description

Purpose:

The Associate Director, QA Validation is responsible for the strategic leadership of Validation (test methods, cleaning, software) and Qualification (instruments, equipment, facilities) programs for R&D. Monitor current trends of global regulatory agencies as they apply to Qualification, Validation and Data Integrity. Understand the impact of changes on other quality systems, communicate the changing regulatory requirements, and drive change. Influence the decision-making process to ensure quality requirements are included when improvement initiatives take place.

Responsibilities:

• Responsible for developing a strategy for the creation, implementation and oversight of an effective GxP Data Integrity Program across the end-to-end product lifecycle. Design a robust quality system for Data Integrity that ensures compliance with regulatory and Abbvie requirements. Proactively prevent data integrity issues before they occur and implement a system that detects, investigates, identifies root cause and implements corrective and preventive actions to prevent re-occurrence.

• Lead the various GxP business units across R&D regarding Data Integrity assessments and risk-based remediation plans / integration into ongoing business.

• Provide subject matter expertise in regulatory requirements, expectations, specifications/ methods/ compendia, manufacturing technology, and/or as they relate to Q&V and Data Integrity.

• Provide active support during regulatory and 3rd party inspections for all Qualification, Validation and Data Integrity topics.

• Collaborate with Operations in the Abbvie Centers of Excellence and implement processes and procedures for Validation, Qualification, Maintenance and Data Integrity Programs relevant to R&D.

• Implement and maintain the global cross-contamination risk assessment Program for R&D.

• Lead, prioritize and resource plans for multiple, complex, competing quality improvement projects and activities

• Recruit, develop, manage and mentor a team of Quality Engineering Professionals, including defining goals and development plans for the group. Provide annual performance reviews for direct reports. Recommend hiring, promotion and disciplinary action for staff.

This position will be on-site at our Lake County Headquarters.

Qualifications

• A 4-year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology or Microbiology.

• 10+ years in the pharmaceutical industry (or related experience) and ~3 years in a leadership role with strong managerial skills.

• Demonstrated ability to lead multi-cultural, multi-functional teams and to work in a complex and matrix environment Ability to make critical, creative and strategic decisions as a result of rapid analysis of available information. Must be able to respond quickly to unplanned events and changing needs while balancing speed, quality and risk to the patient and for the business.

• Key leadership competencies include relationship-building, ability to influence at all levels, knowledge of the business, sound judgment, fostering teamwork, conflict resolution, strong oral and written communication skills and excellent interpersonal skills

• Ability to provide innovative ideas to improve quality and compliance that create value, including seeking new information and external insights. Demonstrated strong project management focus, as well as focus on execution of strategic decisions, while balancing conflicting priorities.

• Membership in professional organizations, e.g. Midwest Discussion Group recommended for remaining current with peer organizations and for providing opportunity to influence industry preferred.

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

Salary: $137,500 - $261,000