Quality & Compliance Team Lead - GMP & Audits

Piramal Pharma Ltd; Riverview (MI); On-site; USD 110,000 - 160,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Team Lead, Quality & Compliance to supervise the QA team and ensure cGMP compliance across all QA activities. You will review batch records, oversee documentation, and support audits and regulatory inspections.

The role requires a Bachelor’s degree in a physical or biological science or engineering, 8+ years in pharma operations or QA, and proficiency with TrackWise, SAP, and Master Control. On-site position with strong data integrity focus.

Qualifications

• Bachelor’s degree in the physical or biological sciences or engineering (Chemistry/Chemical Engineering preferred).
• Minimum eight (8) years’ experience in pharmaceutical operations, regulated life sciences, or quality assurance; 2–5 years supervisory experience preferred.
• Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
• Strong computer skills with MS Office (Word, Visio, Excel), Relational Databases, Reporting and statistical tools.
• Proficient in TrackWise, SAP and Master Control.

Responsibilities

• Review batch production records to ensure GMP conformance and timely approval.
• Walk production areas to promote cGMP and address deviations with staff; document impact and prevent recurrence.
• Assist QA administrative duties; issue master production records and labeling; maintain document tracking systems.
• Support internal/external audits and regulatory inspections; participate in audit findings and corrective actions.
• Prepare/review Analytical Methods Validation, Cleaning Validation, and Process Validation reports.
• Provide data and information for operations or clients; identify trends and propose corrective actions.

Skills

TrackWise

SAP

Master Control

Education

Bachelor’s degree in physical or biological sciences or engineering

Tools

MS Office

Job description

Piramal Pharma Solutions is seeking a Team Lead, Quality & Compliance to supervise the QA team and ensure cGMP compliance across all QA activities. You will review batch records, oversee documentation, and support audits and regulatory inspections.

The role requires a Bachelor’s degree in a physical or biological science or engineering, 8+ years in pharma operations or QA, and proficiency with TrackWise, SAP, and Master Control. On-site position with strong data integrity focus.