QA & Compliance Lead — GMP & Audits

Piramal Pharma Solutions; Riverview (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Solutions in Riverview, MI seeks a Team Lead, Quality & Compliance to supervise the QA/Compliance Team and ensure cGMP adherence across all activities with a focus on regulatory readiness. The role involves reviewing batch production records and analytical data, supporting audits and inspections, and maintaining robust document control to sustain data integrity.

You will drive quality systems improvement, mentor staff, and collaborate cross-functionally to resolve deviations,

Qualifications

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

Responsibilities

• Review batch production records to ensure GMP compliance and conformance with SOPs and approved documents.
• Actively walk production areas to promote and ensure cGMP adherence, addressing deviations in real time.
• Support QA administrative duties such as issuing master production records and labeling, and document tracking.
• Support internal and external audits and regulatory inspections, including data gathering and audit follow-up.
• Prepare and review Quality Systems reports and associated documentation (e.g., Analytical Methods Validation, Cleaning Validation).
• Participate in training and maintenance of Project QA training files and data integrity initiatives.

Job description

Piramal Pharma Solutions in Riverview, MI seeks a Team Lead, Quality & Compliance to supervise the QA/Compliance Team and ensure cGMP adherence across all activities with a focus on regulatory readiness. The role involves reviewing batch production records and analytical data, supporting audits and inspections, and maintaining robust document control to sustain data integrity.

You will drive quality systems improvement, mentor staff, and collaborate cross-functionally to resolve deviations,