Sr. Manager Quality Control

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 110,000 - 160,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Sr. Manager, Quality Control to lead Analytical and Microbiology Quality Control laboratories in Lexington. You will provide strategic direction, ensure regulatory compliance, and drive continuous improvement across testing activities and quality systems.

The role requires extensive cGMP knowledge, strong leadership, and experience managing budgets and audits. You will interact with regulators and project teams to uphold product quality and lab readiness.

Qualifications

• B.A. or B.S in scientific related field 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.

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 for review/incorporation into routine operations
• Establish short and long-range plans for testing activities in scope of priorities and regulatory requirements
• Oversee laboratory instrumentation activities including procurement, qualification, maintenance, calibration
• Establish, implement, and manage Laboratory Programs and/or Policies, SOPs, and good record keeping practices
• Oversee all quality investigations within the departments (deviations, CAPA and LIR)
• Ensure Lab is a constant state of compliance and Inspection Readiness (PIR)
• Ensure suitable laboratory safety procedures are in place
• Ensure department training program in place for ongoing development
• Ensure department technical expertise evolves with industry
• Provide information regarding QC systems to regulatory personnel during inspections
• Analyse and trend sample results and perform statistical studies/KPIs
• Develop mechanisms to adjust testing schedules to changing priorities
• Serve as liaison with corporate data, documentation, and review center
• Interact with project managers, clients, consultants, and regulators
• Oversee development, execution and implementation of quality improvement plans
• Oversee equipment/software procurement and qualification (LIMS, Empower)
• Perform CAPA-related actions
• Support internal/external audits and CAPAs
• Support Cross Functional Quality and Operational activities
• Create environment for continuous improvement
• Lead and mentor QC staff
• Allocate department resources to meet goals/timelines

Skills

cGMP regulations

Quality leadership

Analytical testing

Regulatory inspections

Budget management

Technical writing

Audit readiness

Education

Bachelor's degree in scientific field

Tools

LIMS

Empower

Job description

Be the First to Apply Division Piramal Pharma Solutions

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 Sr. Manager Quality Control

Job Description 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

Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.

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.