Sr. Manager Quality Control

Piramal Pharma Ltd•Lexington, KY

2d•Onsite

About The Position

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) that provides comprehensive, end-to-end development and manufacturing solutions throughout the drug lifecycle. They operate a globally integrated network of facilities across North America, Europe, and Asia, offering a wide array of services including Drug Discovery Solutions, Process & Pharmaceutical Development, Clinical Trial Supplies, and Commercial supply of APIs and Finished dosage forms. They also specialize in the development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. As an integrated service provider with diverse technological experience, Piramal Pharma Solutions serves both Innovator and Generic companies worldwide. This specific role is within the Analytical Quality Control (AQC) department, located in Lexington, and reports to the Director of Quality.

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
Five (5) years’ management experience
Must have experience working within a GMP parenteral/sterile manufacturing environment
Strong/demonstrated knowledge of cGMP regulations
Possess excellent technical writing and oral communication skills

Nice To Haves

Contract manufacturing a plus
Six Sigma Green Belt, Benchmarking and Project Management experience preferred
Ability to travel as needed

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, EMA, PMDA, Other Applicable Agencies as required, and 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 is a constant state of compliance and Sustains 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
Analyse 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
Serve as liaison with the corporate data, documentation, and review center
Interact directly with project managers, clients, consultants, and regulatory agencies
Oversee the development, execution and implementation of quality improvement plans within the QC Department
Oversee the identification, procurement, qualification and implementation of new laboratory equipment, and software platforms (i.e. LIMS, Empower, etc.) as needed
Perform gap assessments and implement CAPAs as needed
Support internal and external audits, agency inspections, responses and CAPAs
Support Cross Functional Quality and Operational activities/projects as needed
Create and support an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safety
Lead and develop/mentor QC members
Assign department resources so that company goals/timelines are achieved