Quality Systems Manager – GMP/ISO Leader (Onsite)

West Pharmaceutical Services, Inc; Jersey Shore (Lycoming County); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Community Involvement

Continuous Learning & Development

Generous PTO

Inclusive & Collaborative Culture

Job summary

West Pharmaceutical Services, Inc in Jersey Shore, PA seeks a QA Systems Manager to lead the Quality Assurance group at the site. You will oversee investigations, CAPAs, change controls, and customer audits, ensuring adherence to global policies and data integrity.

The role focuses on driving quality improvements, managing cross-functional teams, and maintaining ISO 15378 / 9001 compliance while supporting audits and regulatory expectations. This onsite position requires 5 days on site.

Qualifications

• Bachelor's degree in science or engineering or related technical discipline required; consideration of relavant work experience with associates degree.
• Minimum 5 years management experience required preferably in a quality role.
• In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
• Experience with SAP systems and MasterControl document management databases.
• Strong written and oral communication skills with ability to lead teams and liaise with customers.

Responsibilities

• Site QA Manager designee for QA Systems and customer engagement activities.
• Manages Customer Complaint investigations and reporting to ensure adherence to global policies
• Prioritize & manage available QA systems resources to ensure on time scheduling and response timelines are achieved for customer audits, notifications responses, management reviews, and customer complaints.
• Ensure that identified CAPA's are implemented on time and able to effectively address the root causes of the issues.
• Ensure data integrity of data generated in or housed within the quaiity systems. Take actions in case of gap identified in terms of data integrity.
• Support validation of facilities and equipment and process. Approve engineering studies and other protocols as required.
• Manage the quality systems group to maintain ISO 15378 / 9001 compliance.

Skills

Quality systems leadership

Public speaking

Multi-tasking

Problem solving

Education

Bachelor's degree in science or engineering or related technical discipline

Tools

SAP

MasterControl

Job description

West Pharmaceutical Services, Inc in Jersey Shore, PA seeks a QA Systems Manager to lead the Quality Assurance group at the site. You will oversee investigations, CAPAs, change controls, and customer audits, ensuring adherence to global policies and data integrity.

The role focuses on driving quality improvements, managing cross-functional teams, and maintaining ISO 15378 / 9001 compliance while supporting audits and regulatory expectations. This onsite position requires 5 days on site.