Allergan Manager, Corporate Quality Computer Systems in Irvine, California

Manager, Corporate Quality Computer Systems

Irvine, California, United States at

2 days agoPost Date

150842Requisition #

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 pharmaceuticals and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.

Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world’s fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description

This position will lead and participate in CSV audits of both internal systems and external vendorsinvolving regulated computerized systems supporting clinical trials (GCP), pre-clinical toxicology studies (GLP), Manufacturing (GMP) and Pharmacovigilance (GPVP) activities. The individual will be involved in audit identification, planning, and risk management. Inaddition, the position will include the training and mentoring of junior auditors as well as providing consultation and compliance advice to applicable business partners across the organization.

1 Proven GxP knowledge and 4+ years of direct CSV auditing experience

2 Understanding of both pre-clinical and clinical processes and systems

3 Bachelor’s degree in a relevant field required, advanced degree preferred

4 Extensive knowledge of global CSV regulatory requirements

5 Knowledge/understanding of the approach and perspectives of regulatory authorities

6 Demonstrated ability to navigate a globally based and culturally diverse organization

  1. Knowledge

1 Strong written and verbal communication skills

2 Excellent negotiation and relationship building skills

3 High degree of organization awareness

4 Demonstrated ability to develop sound solutions to complex problems

5 Ability to ensure strategic risk focus and prioritize activities in response to the myriad of complex, inconsistent, and constantly evolving global regulations and expectations