Sr. Manager Quality Control

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 120,000 - 180,000; Full time

Job summary

Piramal Pharma Solutions Inc. is seeking a Sr. Manager of Quality Control in Lexington to lead Analytical and Microbiology QC operations.

You will provide strategic direction to improve quality, efficiency, and standardization across the QC department, ensuring regulatory readiness and compliance with FDA and global guidelines. Reporting to the Director of Quality, you will manage budgets, oversee validation and testing programs, and mentor QC staff while driving continuous improvement and risk

Qualifications

• Minimum 10 years in a regulated cGMP environment with 5+ years in management.
• Experience in GMP parenteral/sterile manufacturing preferred.
• Strong knowledge of cGMP regulations and quality systems.

Responsibilities

• Direct oversight of Quality Control Laboratories and testing activities.
• Monitor budgets and department performance against revenue goals.
• Ensure regulatory readiness and inspection readiness across QC operations.
• Lead CAPA, deviations, and investigations with effective problem solving.
• Develop and maintain SOPs, policies, and good record-keeping practices.

Skills

cGMP knowledge

Regulatory compliance

Quality leadership

Technical writing

Education

Bachelor's degree in Life Sciences

Tools

LIMS

Empower

QA software

Job description

Job Title Sr. Manager Quality Control

Business: Pharma Solutions Department: Analytical Quality Control (AQC) Location: Lexington

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

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries.

PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products.

In addition, one of PPL's associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area.

Further, PPL has a minority investment in Yapan Bio Private Limited.

In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.