Quality Assurance Manager

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

 

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

 

This position is responsible for leading quality engineering and quality control laboratory including the receiving quality inspection team in the development and maintenance of an effective QMS system. This requires improving quality systems within the scope of the role, providing oversight of internal quality metrics, and responding to customer quality inquiries.  This individual will drive short term and long-term actions to achieve business goals, while deploying strategic and practical improvements to drive efficiency and accuracy.

Scope of the Role

 

• Direct oversight of Quality Control Laboratory personnel and Quality Engineering; including but not limited to training/re-training employees, documenting employee performance, participating in performance management cycles to provide written and verbal. feedback, and partnering with others to drive conflict resolution within organization.
• Develop personnel to ensure consistent, effective, and efficient quality control activities aligned with department and organizational objectives.
• Assess, select, develop, and retain talent necessary to support the department and organizational objectives.
• Oversight of Calibration, GMP Audits for Retailers, Supplier Quality Sampling / Testing Programs, Stability Monitoring, COAs, and Internal Quality Metrics.
• Periodic communication of quality metrics to internal customers, including identification of deficiencies and initiation of actions to address. Provide quality metrics as inputs to Management Review/ Quality scorecard.
• Partner with Operations to drive quality culture, including training and education, communication, and activities to support the company quality policy.
• Support the Internal and External nonconforming material process, communicating with internal teams to ensure quality metrics are consistently met and escalating issues as needed. Ensure effective implementation and consistent application of the site nonconforming material process.
• Continuous improvement of site quality control systems to ensure effective and efficient controls for product quality.
• Coordinate responses to third party testing failures, including sample inspection, internal sampling and testing, and portal entry.
• Responsible for keeping current with, maintaining, reviewing, and implementing any applicable regulations and standards, supporting internal audits to various standards.
• Support effective implementation of all GMP requirements and understand how it affect products/processes supported and/or owned.

Experience Required

 

• Bachelor’s Degree from an accredited institution in Engineering, Quality Engineering, or other technical fields
• Minimum of 10 years of experience in pharmaceutical industry, including 3 years in a leadership position. Quality leadership/medical device experience preferred.
• Working knowledge of applicable regulations and standards for medical device industry
• Strong understanding of statistically valid sampling practices with an ability to create sampling plans to meet specific needs
• Effective leadership, facilitation, and presentation skills, with the ability to function effectively in a team environment to gain the cooperation of individuals across the business
• Demonstrated ability to work with and manage internal resources and outside contractors.
• Strong analytic/problem solving skills with the ability to convert strategies into actionable plans and processes
• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands 
• Strong verbal and written communication skills in English, with demonstrated ability to successfully work with peer group and frontline organization 
• Proficiency with PC skills such as Word, Excel PowerPoint, and accounting software with the ability to quickly learn various in-house software applications
• Able to practice sound and ethical j