Quality Validation Manager
- Employer
- Ipsen Biopharmaceuticals, Inc.
- Location
- Cambridge, MA, United States
- Start date
- Dec 18, 2018
View more
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
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.
Company
Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.
- Website
- https://www.ipsenus.com/
- Phone
- 617-679-8500
- Location
-
1 Main Street
Unit 700
Cambridge
MA
02142
United States
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