Sr. Manager Quality Control

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Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Job Description

Job Overview

Reporting to the Director of Quality, the Sr. Manager, Quality Control has responsibility for the Analytical and Microbiology Quality Control (AQC/MQC) laboratories. The position will provide strategic direction and leadership to improve quality, efficiency, process standardization, and capabilities of the Quality Control Department.

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, 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

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
Ability to travel as needed.

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