Integrated Quality & Compliance Lead

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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 Integrated Quality & Compliance Lead

Job Description

The role involves providing comprehensive Quality Assurance support through document review and QMS management, including the review and approval of protocols and SOPs. The candidate will act as an SME for QA activities during night shifts and support continuous quality improvement through trend analysis and risk assessment activities. Responsibilities also include managing the Approved Supplier List (ASL) and supporting electronic quality systems to ensure operational efficiency and regulatory compliance. Working hours will be as per US time zone. This position will support Lexington site.

1) Document Review & QMS Support:

• Review and approve protocols, SOPs, and provide support to the Quality Management System (QMS)

2) SME QA Support:

• Provide subject matter expert (SME) QA support during night shifts

3) Risk & Trend Analysis:

• Perform trend analysis and conduct risk assessments to support quality improvements

4) Supplier Management: