Senior Quality Systems & Compliance Leader

Piramal Pharma Limited; Northern (KY); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Sr. Manager Quality Systems & Compliance to lead the site’s QA activities in a cGMP environment. You will oversee audits, regulatory inspections and the maintenance of quality systems and documentation.

The role requires a strong background in QA leadership, regulatory submissions experience, and proficiency with quality systems tools including TrackWise, SAP and MasterControl. A bachelor’s degree in a relevant science or engineering field is required.

Qualifications

• Bachelor's degree in the physical or biological sciences or engineering; Chemistry/Chemical Engineering preferred.

Responsibilities

• Audit internal and external audits and regulatory inspections; participate in responses and maintain QA retain inventory.
• Prepare or review Annual Product Reviews, Non-Conforming Material Reports, Investigation Reports and validation documentation.
• Oversee CAPAs, document reviews, environmental monitoring, quality metrics, quality agreements, TrackWise events, deviations, OOS/OOT investigations, procedures.
• Perform routine and ad hoc quality systems reporting, trend analysis and management review support.
• Participate in risk management activities and maintain risk documentation.
• Manage the QA Systems team, training activities, training records and training module development.

Skills

GMP knowledge

Auditing

Regulatory communication

Education

Bachelor's degree in physical or biological sciences or engineering

Chemistry/Chemical Engineering preferred

Tools

TrackWise

SAP

MasterControl

Job description

Piramal Pharma Solutions is seeking a Sr. Manager Quality Systems & Compliance to lead the site’s QA activities in a cGMP environment. You will oversee audits, regulatory inspections and the maintenance of quality systems and documentation.

The role requires a strong background in QA leadership, regulatory submissions experience, and proficiency with quality systems tools including TrackWise, SAP and MasterControl. A bachelor’s degree in a relevant science or engineering field is required.