Associate Mgr Global Quality Systems – CAPA & Deviation - NJ in Summit, NJ at Apex Life Sciences
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:
- 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: email@example.com