Allergan Director, Quality - Drug Substance Operation (DSO) in Irvine, California

Director, Quality - Drug Substance Operation (DSO)

Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/5618/other-jobs-matching/location-only

Jun 06, 2018Post Date

180536Requisition #

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

Job Summary

Plans, organizes and leads Allergan’s Drug Substance Operation (DSO) from a Quality perspective. Ensures the products made at both DSO sites meet all corporate and regulatory expectations. Develops, maintains and implements quality systems for Biologic drug substance commercial and clinical manufacture.

Supports facility planning, design, validation, regulatory agency submissions and technology transfer to the sites.

Reviews and approves Standard Operating procedures and Master documents for biologic product manufacturing and quality assurance.

Develops the QA management team to ensure they are equipped with the necessary skills to build an organization that will meet emerging and future needs.

Work collaboratively with Research and Development and Global Pharm Tech (GPT) on areas such as:

  • New Product development

  • Drug substance characterization

  • Second Generation method improvement and transfer as required

  • Drug substance Cell Based Assay

  • Transfer of DS1 to BLI

  • Commercial licensing of BLI

  • Quality system oversight of GPT Cell based Potency Assay and development areas

Work with the finished product manufacturing site on potency management.

Supports the stability program for bulk toxin.

Requirements

  • BS degree required (Masters or PhD preferred)

  • 15 years Biopharma experience in Management and development of a Quality systems program

  • Front line Inspection Management required

  • Biologics experience required

Education

  • BS degree required (Masters or PhD preferred)

Equal Employment Opportunity Employer

Allergan is 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, protected veteran status, disability, or any other protected status.