Quality Validation Manager

Location
Cambridge, MA, United States
Posted
Aug 20, 2018
Ref
R-00317
Discipline
Quality, Quality Control
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Quality Validation Manager

Company:
Ipsen Bioscience, Inc.

Job Description:

Duties:

Provide leadership to internal (staff) and external (contract) validation resources to ensure the successful delivery of computerized systems validation activities. Lead and support key continuous improvement initiatives across the functional area to drive a lean, risk based validation lifecycle. Utilise effective change management and ensure that the implementation of improvements is robust for sustainable change. Define and implement validation policies, standards and guidelines. Serve as validation representative for key site and corporate quality initiatives when appropriate. Establish and maintain Key Performance Indicators (KPIs) to monitor performance and to identify improvement opportunities. Provide leadership and expertise for the investigation and resolution of non-conformances encountered during validation activities and site Unplanned Events. Present validation topics during regulatory / internal / customer audits. Review proposed Change Controls (including complex changes) to assess the impact on the validated status and determine the validation strategy as required. Generate, peer review and approve technical documentation. Mentor and coach junior members of the Validation team to enhance the level of experience and expertise within the department.

Requirements:

Bachelor's degree (or foreign equivalent) in Life Sciences, Technology, or a related field; and minimum five (5) years of GxP CSV experience within a relevant regulated industry (pharmaceutical, biotechnology or medical devices) including the following: Expert knowledge of the compliance requirements and current industry standards / best practices pertaining to CSV including EudraLex Annex 11, 21 CFR Part 11, 21CFR Part 820, GxP and GAMP 5; Technical and practical understanding of the Validation requirements for various Equipment & Computerized systems like eDMS, Serialization, ERP, LMS, QMS, HPLC, LIMS and Standalone Laboratory Systems; Understanding of quality risk assessment principles and tools and their application throughout a risk based qualification lifecycle; Basic knowledge of Computer applications and Relational Databases like SQL/Oracle; and experience of presenting during regulatory audits (i.e. FDA, EMA, ANVISA). Travel required up to 20%.

To apply, please e-mail resume to Corey Mathison at corey.mathison@ipsen.com referencing job code 11926.7

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.