Manager, Quality Assurance

This is an onsite position requiring the team member to be onsite 5 days a week.

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World war 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

• This position will lead the Quality Systems team within the Quality Assurance group at the Jersey Shore site.
• This role is responsible for the management of the team and the coordination of all activities.
• Focus is to drive quality improvement activities in operations by executing quality improvement projects, providing relevant data and data analysis as well as supporting customer complaints, customer audits, changer controls, CAPAs and operation and engineering led improvement activities.
• The team will launch or support the publication of relevant quality reports like APRs or monitoring reports. All relevant activities around GMP compliance also fall into the responsibilities of the team.

• 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 that identified Change Control’s are implemented on time and able to effectively.
• Manage cross functional teams to drive product quality improvement projects.
• Ensures compliance with Customer Agreements and Specifications, Applicable ISO standards and regulations.
• Manage the quality systems group to maintain ISO 15378 / 9001 compliance.
• 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.
• Participate in technology transfer activities including risk assessment, equivalency studies and part number setup.
• Support validation of facilities and equipment and process. Approve engineering studies and other protocols as required.
• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.
• Manages and support Customer and Corporate Audits.
• Manage and support post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.
• Support the ongoing update of the QMS in line with emerging issues or changes to regulatory expectations.
• Generate, review, or approve Quality Assurance related documentation required for product.
• Other duties as assigned.

• Bachelor’s degree in science or engineering or related technical discipline required. Consideration of relavant work experience with associates degree.