Manager, Quality Assurance - CSV

Highly Competitive Salary
  1. Permanent
  2. Officer /Associate
  3. United States
Posting date: 24 Jun 2019

ProClinical is currently seeking a Manager of Quality Assurance for a pharmaceutical company located in Pennsylvania. Successful candidate will work with the business and the IT department to ensure that the infrastructure and GxP software applications used by the client to conduct their business, are maintained in a regulatory compliant state.

Job Responsibilities

  • Developing and reviewing validation deliverables.
  • Preparing and reviewing changes to validation systems through formal change control process and implementation.
  • Working closely with the Global Quality Systems leadership and under the direct supervision of the Head of CSV function.
  • Contributing to the creation and maintenance of quality related policies and procedures.

Skills and Requirements

  • BS in Computer Science or equivalent degree and experience.
  • 5-7 years' experience working in the pharmaceutical industry.
  • Functional understanding of the drug development life cycle from discovery through post approval.
  • In-depth knowledge of 21 CFR Part 11, Annex 11 and GAMP 5 best practices, regulations and guidelines.
  • Background in technology including infrastructure, hardware and application implementation.
  • Experience with software development lifecycle methodologies.
  • Ability to communicate effectively and proactively with superiors and peers.
  • Excellent oral and written communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.