Director, Quality Control Laboratories


Job ID 19-00132

Industry Pharma

Job Type Permanent

Location Amityville, NY

Description

Summary:
Responsible for compliance of laboratory operations with established SOPs, FDA regulations as well as compendial requirements.
Ensures thorough investigations are performed leading to the assignment of root causes and the implementation of effective corrective/preventive actions (CAPA) to minimize the possibility of recurrence.
Supports analytical submissions as well as Pre-Approval inspection support. Direct the technical staff of Quality Control and all documentations, which support CMC regulatory submission.
Participates in regulatory agency inspections as required.
Develops and mentors direct and indirect reports.
Directs the generation and implementation of performance and training programs for Quality Control personnel.
Ensures that departmental performance adheres to established performance metrics. Ensures departmental tasks are completed by their established target dates.
Responsible for the assignment of the laboratory disposition of test samples.
Interfaces with R&D and provides feedback on analytical test method development and validation efforts.
Embraces the concept of Continuous Improvement to optimize laboratory performance.
Maintains laboratory operating costs within established budgets.
Implement and revise SOPs as deemed necessary
Responsible for Raw Material, Finished Products and Stability Departments



Qualifications

Qualifications: 
Must have proven interpersonal skills, and be able to direct the activities of subordinates with a wide range of skill levels.
Well versed in the regulatory requirements (cGMP) of the pharmaceutical industry, and will have demonstrated strength in problem solving and resolution.
Must have strong skills / experience with various types of laboratory testing techniques and instrumentation.
Excellent computer and software skills.
Excellent problem solving aptitude, communication and multi-tasking skills.
Excellent verbal and written communication skills.

Education and Experience: 
B.S. / B.A. in Chemistry or related discipline with 10 years' experience in pharmaceutical sciences or
M.S. in Chemistry or other related discipline with 5 years of experience in pharmaceutical sciences.
Minimum of 8 years of demonstrated excellence in chemical and/or pharmaceutical quality (cGMP) with an emphasis on Analytical Testing.
Minimum of 5 years of supervisory or management experience.

Ideal Candidate:
Has a minimum of 10 years of experience in the pharmaceutical industry, liquid dosage preferred.
Minimum of 5 years of management experience over a team of 45 employees or more.
The right candidate will also have experience working within the Micro lab.