Senior GXP Auditor
- Employer
- Ipsen Biopharmaceuticals, Inc.
- Location
- Cambridge, Massachusetts
- Start date
- Oct 11, 2021
View more
- Discipline
- Administration, Accounting
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
Title:
Senior GXP AuditorCompany:
Ipsen Biopharm LtdJob Description:
An exciting opportunity has arisen for a GxP (GMP/GDP focus) Quality Auditor to join our dynamic Global Audit team.
The jobholder will be accountable for scheduling, conducting, and reporting internal and external GxP audits with a focus on GMP/GDP regulations medical devices and food supplements.
The position requires expertise in a broad range of audits with demonstrable experience in sterile and biological manufacturing processes. The role encompasses a broad range of audit types eg: API, Drug Product, sterile processes, packaging, quality control, distribution, commercial operations and quality systems and will involve both on site and remote auditing as routine. Travel will be required internationally.
They will be a strong team player and experienced lead auditor able to manage an audit team for more complex audits. They will require expertise in written and oral communication in English and must be able to produce robust audit reports and findings.
To be successful in this role, you will have:
- Bachelors degree in a scientific or health-related field
- Lead auditor qualification/certification
- Demonstrable experience of a minimum of 5 years auditing experience across all entities and systems for GMP/GDP
- Must have expertise in audits of sterile and or biological manufacturing
- Minimum 5-10 years’ experience in Quality within the pharmaceutical sector
- Proven excellent written and verbal communication
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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