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Director of Quality Control in West Caldwell, NJ at Synerfac

Date Posted: 3/27/2019

Job Snapshot

Job Description

Primary Job Functions:
The Director, Quality Control (QC) identifies requirements and plans, develops, implements and maintains resources, including systems, processes, equipment and people, to analyze incoming, in process and finished products against predetermined criteria using approved test methods. This individual will provide tactical leadership to Quality Control, ensuring the execution of responsibilities in a complete, compliant and timely fashion. This position indirectly and directly manages people and is responsible for all work completed within the QC group for pharmaceutical and combination (pharmaceutical/medical device) products.
1.Ensure compliance with all applicable US FDA, US DEA and EMA regulations and expectations related to laboratory operations. Stay abreast of and provide feedback to changes in such regulations and expectations and provide implementation strategy to remain compliant.
2.Ensure compliance to all compendial changes (as applicable), i.e. USP, EP etc.
3.Ensure the QC laboratory is always inspection ready.
4.Ensure compliance with all customer expectations related to laboratory operations. Maintain trusting relationships with customers with regard to laboratory operations performance and results.
5.Be the primary QC contact for strategic decisions with internal customers, including Supply Chain, Production, and Quality Assurance. Maintain transparent, detailed, open and timely communication with internal customers to permit continuous, easy identification of issues and testing/release progress.
6.Participates in and facilitates global Quality Control System harmonization activities to develop best practices approach to laboratory operations which meets all existing customer expectations.
7.Work with Quality Technical Services (QTS) group to ensure methods are validated and equipment is qualified to generate valid results. Coordinate improvements and harmonization of methods and equipment through QTS.
8.Oversee quality and technical processes at contract laboratories and contractors / temporary staff performing work on behalf of Quality Control, to ensure they are consistent with the standard.
9.Generate and maintain metrics work conducted in QC.
10.Lead and manage direct and indirect reports to achieve goals and objectives in a consistent manner. Foster the professional development of the QC team.

  Job Requirements  

QUALIFICATIONS/REQUIREMENTS:
•Bachelor's Degree required. Masters Degree preferred
•15+ years•of Pharmaceutical experience in Chemistry.
•Experience working for a CMO or Contract Laboratory
•Previous Director and Administrative Level Skills
•Strong Leadership and Communication Skills
•Confidence in hosting laboratory portions of Regulatory Inspections and Customer Audits.