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 a blended-branded business to win in self-care.
Description Overview
The External Operations Quality Assurance Group Leader is responsible for the oversight and management of the Quality Management System (QMS) for Perrigo external product(s) suppliers, monitoring compliance and execution according to SOPs, and identifying and mitigating risk to the company. This position will lead a team of 2-5 External Quality Professionals, including oversight of day-to-day activities and performance appraisals. This is a full-time hybrid position, with a minimum of 3 days onsite in the Perrigo Allegan office.
Scope of the Role
- Qualification and approval of External Suppliers per procedures.
- Acts as primary contact/facilitator for External Suppliers on all quality related issues.
- Creation and maintenance of quality agreements with External Supplier per procedures
- Quality oversight of new product development with External Supplier.
- Key participant in project teams and support for team members, as needed.
- Manages and communicates all change control activities related to equipment, facilities, process, materials, and systems of the external manufacturer to appropriate SME’s.
- Leads investigations related to operational deviations according to cGMP, ensures external suppliers and sites are made aware of corrective and preventative actions, reviews and approves documents (i.e. deviations) , works with departments to develop, evaluate and implement action plans.
- Recommends disposition of all involved externally supplied products associated with the deviation investigation.
- Reviews completed investigations from team members for thoroughness prior to submission to external operations QA management for final approval.
- Provides technical assistance on all quality related issues for products produced at an external supplier.
- Leads process and system audits according to established audit plan.
- Reports audit findings to process owners and management.
- Facilitates development of corrective action plans by process owners, tracks corrective actions, verifies implementation of corrections, and assesses the effectiveness of corrective actions.
- Reviews audit observations issued by team members and escalates issues to management when appropriate.
- Promotes development and succession planning for direct reports within area of responsibility
- May assist with projects involving modifications or upgrades to processes and may provide leadership and direction within area of responsibility.
Experience Required
- Bachelor’s degree in a scientific discipline or closely aligned field, with Master’s degree preferred.
- Six to eight (6-8) years professional experience in Quality or Operations, with in-depth knowledge and experience in Drug products.
- Experience in other pharmaceutical categories such as, Sterile, Medical Devices, API, and/ or Dietary Supplements is preferred, but not required.
- Strong grasp of cGMP standards and requirements in an FDA regulated industry and the ability to interpret and apply these regulations and their application.
- Excellent oral and written communication skills at all levels of the organization and good interpersonal and relational skill.
- Demonstrated leadership ability and demonstrated ability to build effective relationships with stakeholders, peers and management.
Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about Total Rewards at Perrigo.
We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV #weareperrigo