External Quality Professional II
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
The External Quality Professional will directly manage all Quality Assurance activities in support of External Operations for domestic CHC and Rx business units, and identify and mediate the risk to the company and monitor the compliance and execution of external manufacturing quality systems.
Job duties include but are not limited to the following:
- Participate in audits at suppliers, as needed. Travel could be up to 20%.
- Create / negotiate and maintain Quality Agreements.
- Measure supplier quality performance, periodically collect and share quality performance metrics. Identify potential trends, working closely with supplier to define possible areas for improvement and associated implementation plan.
- Collect supplier quality documentation necessary to support regulatory submissions.
- Hold appropriate periodic quality meetings with supplier representatives, as needed.
- Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of Deviations, Complaint investigations and CAPAs.
- Collect APR related information and data per Perrigo requirements.
- Manage supplier changes through change control process.
- Write protocols, technical documents, and assessments.
- Bachelor’s degree in a scientific discipline or closely aligned field.
- Minimum four years professional experience in pharmaceutical Quality or Operations.
- 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 skills.
We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.