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Associate Mgr Global Quality Systems CAPA & Deviation

Newark Metro Area, NJ

Post Date: 02/05/2018 Job ID: JN -022018-20893 Job Type: Clinical
Description:
The Associate Manager, Global Quality Systems CAPA & Deviation, is responsible for process and system ownership of the CAPA and Deviation quality system elements. In this role, the incumbent will serve as business process owner for the eQRMS electronic CAPA and Deviation modules including all associated governing procedures. This is a highly visible role with global responsibility and cross-functional influence that has an impact on departmental performance and broad quality initiatives requiring both strategic and tactical decision making. In this capacity, the Associate Manager will be the primary subject matter expert for GMP CAPA and Deviations across the company.

Function as the Quality System Owner for the CAPA and Deviation systems and all associated processes and procedures.
Plan and implement lifecycle changes and system level enhancements through partnership with IT Developers and Business Analysts.
Author and maintain all standards, policies, procedures, work practices and job aides that support the CAPA and Deviation system.
Develop and conduct user training and manage system access.
Provide input to and execute the strategic roadmap for the electronic CAPA and Deviation modules in eQRMS.
Create and distribute all metrics, analytics and performance indicators for CAPA and Deviation.
Collaborate with cross-functional system partners and represent the CAPA and Deviation user community in all governance and life-cycle related capacities.
Own and implement a consistent and effective document hierarchy plan for CAPA and Deviation, including local and global elements.


Skills:
Must have expert GMP, Quality, and in-depth risk management knowledge, particularly in the areas of CAPA and Deviations.
Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, Documentum and ComplianceWire.
Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.
Must be able recognizes risk and develop contingency plans.
Must understand continuous improvement and be able improve the efficiency and productivity of the CAPA and Deviation quality systems.
Must be Able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
Must complete routine tasks independently and be confident in making complex decisions in their subject matter area, consulting with supervisor for decisions outside of established processes.
Must be familiar with the roles and responsibilities of common GMP functional areas such as Quality, Pharmaceutical Development, Technical Operations and Manufacturing.

Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.

Must be action-oriented and customer-focused and skilled in the following areas:
o decision-making
o building relationships
o problem solving
o conflict management
o planning and organizing
o resource allocation
o analytical thinking.
Must possess an independent mindset and tenacity.
Must have a thorough knowledge of PC productivity tools such as Word, Excel, PowerPoint, and Visio (Expert knowledge in the utilization of Excel is preferred).


Must have expert GMP, Quality, and in-depth risk management knowledge, particularly in the areas of CAPA and Deviations.
Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, Documentum and ComplianceWire.

Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.

Must be able recognizes risk and develop contingency plans.

Must understand continuous improvement and be able improve the efficiency and productivity of the CAPA and Deviation quality systems.

Must be Able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
Must complete routine tasks independently and be confident in making complex decisions in their subject matter area, consulting with supervisor for decisions outside of established processes.
Must be familiar with the roles and responsibilities of common GMP functional areas such as Quality, Pharmaceutical Development, Technical Operations and Manufacturing.

Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.

Must be action-oriented and customer-focused and skilled in the following areas:
o decision-making
o building relationships
o problem solving
o conflict management
o planning and organizing
o resource allocation
o analytical thinking.
Must possess an independent mindset and tenacity.
Must have a thorough knowledge of PC productivity tools such as Word, Excel, PowerPoint, and Visio (Expert knowledge in the utilization of Excel is preferred).




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