Sr. Manager AQC

Piramal Group•Lexington, KY

12d

About The Position

Reporting to the Director of Quality, the Sr. Manager, Analytical Quality Control (“AQC”) has responsibility for the Analytical Quality Control AQC laboratories. The position will provide strategic direction and leadership to improve quality, efficiency and capability.

Requirements

B.A. or B.S in scientific related field, Biology, Life Science, Chemistry, or related scientific discipline preferred
Minimum of ten (10) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience
Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
Strong/demonstrated knowledge of cGMP regulations
Possess excellent technical writing and oral communication skills

Nice To Haves

Six Sigma Green Belt, Benchmarking and Project Management experience preferred

Responsibilities

Direct oversight of activities performed within Quality Control Laboratories
Monitor revenue goals ensuring that Laboratories meet or exceed expectations
Develop and manage department budgets
Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operations
Establish short and long-range plans for the timely and efficient execution of the testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)
Apply necessary oversight to the stability study program and ensure current regulatory guidelines are followed
Oversee laboratory instrumentation activities including procurement, qualification, preventative maintenance, and calibration
Establish, implement, and manage Laboratory Programs and/or Policies, SOPs, and good record keeping practices that are compliant with current regulatory requirements
Oversee all quality investigations within the departments (deviations, CAPA and LIR)
Ensure Lab Sustain Permanent Inspection Readiness (PIR)
Ensure suitable laboratory safety procedures are in place
Ensure that there is a department training program in place so that department staff are continuously developing and are current with industry practice
Ensure that department technical expertise and capabilities are constantly evolving and current with industry.
Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries
Analyze and trend sample results and perform statistical studies and evaluations of key performance indicators
Develop mechanisms and structures to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs.
Encourage an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safety
Lead and mentor individual group members
Assign department resources so that company goals/timelines are achieved