Director Quality Control - Essex County, NJ | Biospace
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Director Quality Control

Omega Management Group

Location:
Essex County, NJ
Posted Date:
6/9/2017
Position Type:
Full time
Job Code:
4809
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
QC, Quality Control,

Job Description


Job Title:   Director, Quality Control

Reports to:   VP Quality and Regulatory Affairs

BASIC JOB FUNCTION:    

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.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1.   Ensure compliance with all applicable US FDA, US DEA and EMA regulations and expectations related to laboratory operations.  Anticipate and provide feedback to changes in such regulations and expectations and provide implementation strategy to remain compliant.  Ensure the QC laboratory is constantly inspection ready.
2.   Ensure compliance with all customer expectations related to laboratory operations.  Maintain trusting relationships with customers such that they feel confident in laboratory operations performance and results.  
3.   Be the primary contact for strategic decisions with internal customers, including Supply Chain, Production, and Quality Assurance.  Maintain transparent, detailed and open communication with internal customers to permit continuous, easy identification of issue status and testing/release progress.  Quickly identify, communicate and resolve issues which have a potential impact to deliver against commitments in a compliant manner.
4.   Work closely with Corporate to develop best practices approach to laboratory related issues, to have a singular approach which meets all existing customer expectations.  Discuss new customer expectations such that the laboratory approach remains as consistent as possible across customers and products.
5.   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.
6.   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 company standard.
7.   Lead and manage direct and indirect reports to achieve company goals and objectives in a consistent manner.  Foster the professional development of QC team members.
8.   Generate and maintain metrics to identify singular issues and trends for routine and non-routine work conducted in QC, including product performance, schedule adherence and laboratory performance issues.




Requirements


KNOWLEDGE AND EXPERIENCE:

1.   BS in Chemistry or other scientific field.  MS or PhD in Analytical Chemistry preferred.
2.   At least 15 years in a Pharmaceutical Quality Control environment, at least 10 of those years managing people.
3.   Experience working for a Contract Manufacturing Organization or Contract Laboratory.
4.   Confidence in hosting laboratory portions of Regulatory Inspections and Customer Audits.

DIRECT REPORTS TO THIS POSITION:

Supervisor, Incoming Materials
Supervisor, Work In Process / Finished Products
Supervisor, Stability
29 indirect reports