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Posted: Wednesday, February 21, 2018 12:12 AM

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Job Description


We are looking for an Associate Manager of Global Quality Systems - CAPA & Deviation - to join our Global Pharmaceutical company located in Summit, NJ. The ideal candidate will have strong experience with CAPA and GMP. This is a initial contract role with a possibility to convert to permanent.

1. PURPOSE AND SCOPE OF POSITION:

  • 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.


2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • 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:
    • decision-making
    • building relationships
    • problem solving
    • conflict management
    • planning and organizing
    • resource allocation
    • 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).

3. DUTIES AND RESPONSIBILITIES:

  • 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 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.

4. EDUCATION AND EXPERIENCE:

  • Minimum 5 years relevant work experience; 1 year of leadership experience preferred; equivalent combination of education and experience acceptable.

For immediate consideration, please email resumes to: mbingham@apexlifesciences.com





• Location: North Jersey, Summit, NJ

• Post ID: 53395497 newjersey
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