Associate Director, Qualification and Validation, Product Development Quality Assurance (On-site)
Associate Director, Qualification and Validation, Product Development Quality Assurance (On-site)
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Salary Not Disclosed
1 Vacancy
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 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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
