Quality & Compliance Team Lead — GMP Champion

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 120,000 - 150,000; Full time

Job summary

Piramal Pharma Limited is seeking a Team Lead, Quality & Compliance to supervise the QA team and ensure strict adherence to cGMP. The role emphasizes batch review, regulatory readiness, and data integrity across production records.

The ideal candidate has a bachelor’s in a physical/biological science or engineering, 8+ years in pharma with 2–5 years supervisory experience, and hands-on use of TrackWise, SAP and MasterControl. Strong regulatory interaction skills are essential.

Qualifications

• Bachelor’s degree in physical/biological sciences or engineering.
• 8+ years in pharmaceutical operations or quality assurance; 2–5 years supervisory preferred.
• Knowledge of GMP and regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q7/9/10).
• Experience with TrackWise, SAP and MasterControl platforms.

Responsibilities

• Supervise Quality & Compliance Team and ensure cGMP compliance.
• Review batch records, SOPs, and regulatory requirements for releases.
• Lead internal audits and support regulatory inspections.
• Address deviations in real time and implement corrective actions.
• Prepare analytical validation, cleaning validation and process validation reviews.
• Maintain data integrity across production data and systems.
• Provide QA training and support document tracking and audits.

Skills

GMP knowledge

QA supervision

Data integrity

Audits & regulatory

Analytical thinking

Regulatory communication

FDA interactions

Documentation control

Education

Bachelor’s in physical/biological sciences or engineering

Chemistry/Chemical Engineering preferred

Tools

TrackWise

SAP

MasterControl

MS Office

Job description

Piramal Pharma Limited is seeking a Team Lead, Quality & Compliance to supervise the QA team and ensure strict adherence to cGMP. The role emphasizes batch review, regulatory readiness, and data integrity across production records.

The ideal candidate has a bachelor’s in a physical/biological science or engineering, 8+ years in pharma with 2–5 years supervisory experience, and hands-on use of TrackWise, SAP and MasterControl. Strong regulatory interaction skills are essential.