Quality Control Supervisor

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 85,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions seeks a QC Supervisor in Sellersville, PA to lead a team of 4–5 analysts performing analytical chemistry and microbiology tests across raw materials, finished products, and environmental samples. You will ensure GMP-compliant operations, investigations, and data reviews to drive quality and regulatory readiness.

The role requires a Bachelor's in a related science, 7+ years in GMP labs, and 5+ years in leadership, with hands‑on expertise in HPLC/UPLC/GC and experience

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related discipline.
• Minimum 7 years of technical laboratory experience in a GMP-regulated environment.
• Minimum 5 years of leadership or supervisory experience.
• Experience with analytical chemistry and/or microbiological testing.
• Hands‑on experience with HPLC, UPLC, and GC instrumentation.
• Knowledge of GMP, FDA, ICH, and USP requirements.
• Experience with Empower, LIMS, and TrackWise preferred.

Responsibilities

• Supervise daily activities of approximately 4–5 QC analysts.
• Plan, coordinate, and prioritize laboratory testing activities to support manufacturing and supply chain schedules.
• Review analytical data generated from HPLC, UPLC, GC, and ICP-MS testing.
• Ensure testing is performed in accordance with approved SOPs, USP, EP and regulatory requirements.
• Coordinate sampling, testing, and laboratory support activities for production operations.
• Lead and manage cleaning validation and cleaning verification programs.
• Facilitate communication and testing activities with external laboratories.
• Perform data review and auditing to support lot disposition decisions.
• Lead OOS/OOT investigations, CAPAs, and change controls.
• Support laboratory inspection readiness and regulatory compliance initiatives.
• Support Empower, LIMS, and TrackWise systems administration.
• Prepare, review, and approve validation and verification protocols and reports.
• Maintain and periodically review departmental SOPs.
• Provide training, coaching, performance management, and development for QC analysts.
• Participate in site quality initiatives and cross-functional project teams.

Skills

Leadership

Analytical skills

Communication

Data integrity

Regulatory knowledge

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

ICP-MS

Empower

LIMS

TrackWise

Job description

Job Title

Quality Control Supervisor

Company Overview

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

Location

Sellersville, PA facility.

Job Description

Piramal Pharma Solutions is seeking an experienced and motivated QC Supervisor to lead a team of Quality Control analysts in the Sellersville, PA facility. This role is responsible for supervising laboratory operations, ensuring compliance with GMP requirements, supporting laboratory investigations, and driving operational excellence within the Quality Control department. The QC Supervisor oversees a team of approximately 4–5 analysts performing analytical chemistry and microbiological testing on raw materials, finished products, environmental monitoring samples, cleaning validation samples, and stability studies.

Key Responsibilities

• Supervise daily activities of approximately 4–5 QC analysts.
• Plan, coordinate, and prioritize laboratory testing activities to support manufacturing and supply chain schedules.
• Review analytical data generated from HPLC, UPLC, GC, and ICP-MS testing.
• Ensure testing is performed in accordance with approved SOPs, USP, EP and regulatory requirements.
• Coordinate sampling, testing, and laboratory support activities for production operations.
• Manage cleaning validation and cleaning verification testing programs.
• Facilitate communication and testing activities with external laboratories.
• Perform data review and auditing to support lot disposition decisions.
• Lead and document OOS, OOT, deviation investigations, CAPAs, and change controls.
• Support laboratory inspection readiness and regulatory compliance initiatives.
• Support Empower, LIMS, and TrackWise systems administration activities.
• Prepare, review, and approve validation and verification protocols and reports.
• Maintain and periodically review departmental SOPs.
• Provide training, coaching, performance management, and development for QC analysts.
• Participate in site quality initiatives and represent QC on cross-functional project teams.
• Other duties as deemed necessary.

Education & Experience

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related scientific discipline.
• Minimum 7 years of technical laboratory experience in a GMP-regulated environment.
• Minimum 5 years of leadership or supervisory experience.
• Experience with analytical chemistry and/or microbiological testing.
• Hands‑on experience with HPLC, UPLC, and GC instrumentation.
• Knowledge of GMP, FDA, ICH, and USP requirements.
• Experience with Empower, LIMS, and TrackWise preferred.

Knowledge, Skills & Abilities

• Strong leadership and team development skills.
• Excellent written, verbal, and interpersonal communication skills.
• Strong analytical and problem‑solving capabilities.
• Proficiency in Microsoft Office applications.
• Knowledge of data integrity principles and laboratory compliance requirements.
• Ability to manage multiple priorities in a fast‑paced environment.

About Piramal Pharma Limited

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.

Equal Employment Opportunity

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.