Sr. Manager AQC at Piramal

Lexington, Kentucky, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Quality Control, Quality Control Laboratories, cGMP Regulations, Laboratory Safety Procedures, Technical Writing, Oral Communication, Statistical Studies, Project Management, Six Sigma Green Belt, Budget Management, Quality Investigations, Regulatory Compliance, Laboratory Instrumentation, Training Program Development, Continuous Improvement, Leadership

Industry

Financial Services

Description

Business: Pharma Solutions Department: Analytical Quality Control Location: Lexington Job Overview 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. Reporting Structure This position reports to the Director of Quality Key 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 QUALIFICATIONS: 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 Six Sigma Green Belt, Benchmarking and Project Management experience preferred

Responsibilities

The Sr. Manager of Analytical Quality Control oversees the Quality Control Laboratories, ensuring compliance with regulatory requirements and improving quality and efficiency. This role involves managing budgets, monitoring laboratory activities, and leading a team to achieve company goals.