Company: BioMarin Europe Limited
Reference: GxP Compliance
Closing Date: 07 Nov 16
Type: Full Time
Salary (£): Competitive
Biomarin is currently looking for a GxP Operations manager, based in Central London. This role will support or lead during external agency inspections, and provide appropriate oversight of regulatory inspection commitments to ensure completion. Activities include designing, developing, and implementing cGxP-related programs to assure compliance with corporate policies and regulatory agencies.
GxP Compliance Manager
Reports to: Director GxP Compliance
This position is located in London, England and will act as a regional representative for the Global Corporate Compliance GxP Operations function. The scope of responsibilities include, but are not limited to oversight of Good Distribution Practices (GDP) processes/activities including transportation, supply chain partner management, and temperature controlled logistics solutions.
This role will support or lead during external agency inspections, and provide appropriate oversight of regulatory inspection commitments to ensure completion. Activities include designing, developing, and implementing cGxP-related programs to assure compliance with corporate policies and regulatory agencies. The incumbent will support the communication of risk to Senior Management, and provide regulatory intelligence monitoring to assist in inspection and audit preparation.
No revenue is generated from this position. There is expected to be minimal capital investment (computer and work space, etc.). The position is intended to reduce BioMarin’s compliance risk and exposure. There may be some additional costs incurred by this position through periodic required travel, primarily to provide inspection support and oversight of distributors.
Degree in Business, Engineering, Science, Pharmacy or Technology.
External: Providers of Contract Services, Regulatory Inspectors, Distribution Partners.
Internal: BioMarin Pharmacovigilance; Medical Information Services; Non-medical Complaints; GMP, GCP and GLP Compliance; Regulatory Affairs, Clinical Development, Technical Operations.
Fluent with Microsoft Office suite programs (Word, Excel, PowerPoint, Access and Project). Oracle EBS. LiveLink. TrackWise
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
All employment offers and resumes are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at BioMarin requests that recruiters are not to contact BioMarin employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with BioMarin.
BioMarin will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of BioMarin.
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