What are the responsibilities and job description for the Associate Director Corporate Quality Compliance Internal Auditor position at Perrigo?
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
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.
Perrigo is seeking an Associate Director of Corporate Quality Compliance Internal Audits
Scope of the Role
- Develops standards and multi-site operating procedures in support of corporate quality compliance goals
- Leads initiatives to improve corporate quality where compliance improvement is identified through audits and monitoring, for example technical transfer, quality investigations, auditing, inspection readiness, and regulatory topics.
- Provides leadership, guidance and communicates trends in the network-wide quality audit community.
- Support supplier qualification where appropriate for high profile or high criticality vendors.
- Perform due diligence assessment of potential acquisition targets.
- Develop and maintain compliance training modules for GMP and GDP annual training.
- Act as business owner for the Trackwise Audit Information Management system. Coordinating system changes and meeting regularly with IT and superuser resources. Monitor system use and communicate best practices.
- Participates in Quality Metrics reviews, quality management reviews
- Arranges for 3rd party/contract audits where outside expertise is required, directing expenditures up to $20K and managing costs according to the project plan.
- Tracks all inspections of Perrigo sites by regulatory authorities and notified bodies, providing guidance to the site for observation responses when appropriate. Capture observations and analyses data for trends for communication to the broader site network, or updates to quality systems.
- Track and coordinate reviews for quality event escalations, including regulatory notifications and product recalls. Maintain applicable metrics for escalated quality events and communicate to senior management.
- Maintain a regulatory intelligence program focusing on changes to GMP regulations and guidance, and trends in regulatory enforcement. Implements relevant changes into Perrigo policies to maintain alignment.
- Identify quality compliance risks proactively and work with CQC and Quality Operations leadership to create and implement mitigation plans.
- Generates ad-hoc metrics reports and responds to information requests related to Quality Compliance metrics for Perrigo leadership, Corporate Communications.
- Frequent interaction with leadership at VP level and above, using negotiation and influence skills to achieve mutually beneficial and compliance outcomes.
Experience Required
- Fifteen plus years of increasingly responsible experience in a large corporate environment; with a proven track record in overcoming business challenges and Bachelor Degree in technical field – engineering, life sciences, pharmacy, healthcare or related fields.
- Technical experience working in GMP environment, roles in QA, QC and audit experience.
- Expertise in drug GMP (Eudralex Volume 4) and device quality (ISO 13485). Experience in GDP, cosmetics, and food/infant formula auditing or oversight is preferred.
- Working understanding of relevant GxP fields, including GCP, GLP
- Conversant in applicable regulatory guidances including PIC/S, ICH, ISO, EU, MHRA and US FDA
- Comfortable in preparing and delivering global regulatory and cGMP training, informative presentations, and summaries to audiences of all levels within organization.
- Travel 30 %
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
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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. #weareperrigo
Salary : $20,000
