We are seeking a driven and technical oriented Manager- Analytics and Data Integrity to lead site analytics web and data quality initiatives within our pharmaceutical operation reporting into Digital Systems organization. This role is central to ensure that all data used in GxP systems are connected accurate secure and in full compliance with AbbVies global program and regulatory standards including FDA EMA and MHRA requirements.
This role bridges the data stream from strategy governance and analytics. This role will lead and implement a site strategy in compliance with regulatory and AbbVie global expectations champion key site initiatives and contribute to the global Data Integrity Center of Excellence. Execute a vision of world class data governance that serves our patients by managing the sites efforts at driving best practices within the data lifecycle.
Responsibilities:
- Set direct and control all department and financial goals budget and objectives for the engineering area assigned.
- Drive and lead the engineering department to meet the site/engineering business strategies; accountable for cost center expenses project budgets and delivery of projects to support required plant/facility projects and programs.
- Responsible for compliance with applicable policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design early risk assessments and implementation of fallback strategies.
- Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes.
- Mitigates risk within functions through sound design early risk assessments and implementation of fallback strategies.
- Recommend and implement business strategies and engineering controls to reduce costs increase efficiency and drive world-class performance.
- Collaborate with peers and cross-functional partners to define action plans timelines and budgets for project goals and manage/plan/assign engineering resources required for execution.
- Analyzes business forces (customers suppliers competitors technologies government regulations) in major markets to identify trends and recommend responses. Independently executes and/or directs others in the execution of the design of products/processes/equipment/systems/facilities by applying novel engineering theories concepts and techniques within the discipline.
- Develop and manage staff through hiring managing performance developing talent and providing clear expectations.
Leadership:
- Manage and guide a team of employees fostering a culture of innovative problem solving and continuous improvement. Build and maintain the teams capabilities to effectively execute analytics strategy ensuring team members possess the necessary skills and tools to excel in their roles.
- Train staff in data best practices.
- Establish strong partnerships with category leads to understand and anticipate their analytical needs across business areas Operations R&D Commercial etc.
Qualifications :
- Bachelors Degree required preferably in Physical or Life Sciences Pharmacy or Engineering
- 12 years of combined experience in Manufacturing QA Engineering R&D in pharmaceutical biologics device or chemical industry
- Direct experience with system development and validation including development of system specifications (DS FS URS) and risk-based validation strategies and validation protocol development and execution.
- Demonstrated knowledge of 21 CFR Part 11 requirements for automated systems in the pharmaceutical or medical device industries.
- Demonstrated problem solving skills and innovative thinking to develop and implement untested solutions.
- Ability to provide technical program leadership including external vendor management and lead cross-functional teams including internal and external resources.
- Excellent communication and influencing skills at all levels of the organization are required to influence diverse ad hoc teams of SMEs.
- Demonstrated project management skills and ability to lead effective change management.
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.
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Work :
No
Employment Type :
Full-time