Director Quality Systems and Data Integrity
Director Quality Systems and Data Integrity
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
Establish Implement lead and manage an effective Global GxP Data Integrity Program supporting Global Operations. Lead business ownership for Quality Operations global enterprise IT systems ensuring system applications support and manage the business effectively. Build an effective strategic business process improvement plan to ensure business processes associated with each respective enterprise system is managed to reflect a bestinclass quality operating system. The role is responsible for ensuring Quality Centers of Excellence associated with global enterprise systems and associated quality system processes are effectively operating to optimize business processes.
Responsibilities:
- Lead the Data Integrity program for AbbVie Operations
- Engage with peers in the industry for baselining and ensuring best in class practices for data integrity DI standards; Assess new regulations and any changes to existing regulations in relation to data integrity.
- Oversee COEs & CoPs for processes associated with Enterprise systems for the Quality Operation: Electronic Document Management System Data Management System Trackwise Empower etc. (May need to also provide oversight to systems used in Operations without formally owning the systems/ processes.
- Effectively manage and execute strategic business opportunities to improve business processes. Lead process improvements new system applications and system changes across the network (internally in the global quality function and across Operations as per the system application).
- Drive harmonization of global processes/data and local fit/gap activities to determine system vs business process change requirements.
- Provide adjunct oversight of regulatory compliance for software development and validation lifecycle activities associated with GxP computerized systems to ensure conformance to cGxPs guidance documents applicable industry accepted standards and AbbVie business requirements.
- Lead Systems integration as applicable and provide oversight of key GMP systems that are added in the network though integrations.
- Provide mentorship leadership and prioritization to staff to execute their respective duties.
Qualifications :
- Bachelors degree required. Preferably in IT Computer/Data Science Healthcare Sciences or Engineering.
- 15 years experience in GMP pharmaceutical biologics and/or medical device manufacturing; 5 years leadership experience.
- 10 years experience in a data and systemsrelated role in a regulated industry
- High level of competence confidence and credibility for interaction with executive management.
- Skilled in the strategy development initiation selection coordination and management of projects and have the ability to solve unique problems.
- In depth knowledge of regulations for Data Integrity and Risk Management including FDA EMA PICs and WHO.
- Skilled in the strategy development initiation selection coordination and management of projects.
- Strong technical and analytical skills with an ability to solve unique technical events across multiple enterprise systems applications.
- Understanding of IT system and its application in the business operation. Knowledge of the business operation in which the enterprise system operates is fundamental.
- Capable to manage multiple priorities and maintain adherence to timelines.
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.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
