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Job Details

GxP Operations Manager

Company: BioMarin Europe Limited
Location:
Reference: GxP Compliance
Closing Date: 07 Jan 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

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.

Requirements:

GxP Compliance Manager

 

Reports to: Director GxP Compliance

Location: London


SUMMARY DESCRIPTION

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.


RESPONSIBILITIES

  • Provide oversight of GDP quality system including distribution related investigations, CAPA, change control, internal audits, and recall coordination.
  • Manage GDP related tasks including, but not limited to: returns management, customer complaints.
  • Lead the generation and update of quality agreements.
  • Deliver GDP training as requested.
  • Support inspection readiness activities during development and commercial manufacturing phases of product lifecycle.
  • Conduct compliance assessments emerging regulations and facilitate continuous process improvements.
  • Ensure appropriate procedures are in place for processing orders including customer bone fide checks and ensuring supply of products is in accordance with regulations.
  • Author, review and approve SOPs and other relevant GDP documentation.
  • Ensure appropriate procedures are in place for receipt, storage and distribution of product at third party facilities
  • Oversight of Third Party Vendors including offsite storage and distribution facilities
  • Maintain the required regulatory licenses for the company (i.e. WDA).
  • Job involves approximately 10% domestic and some international travel.
  • Other duties as assigned.

 

SCOPE

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.

 

EDUCATION

Degree in Business, Engineering, Science, Pharmacy or Technology.

 

EXPERIENCE

  • Experience in Biotechnology, Pharmaceutical, or Medical Device industry.
  • Lean and/or Six Sigma certification from a recognized certifying body or global organization engaged in Lean Six Sigma.
  • Prior experience in Quality Assurance, GxP Auditing within a Quality Assurance and/or Compliance function, or having positions in Regulatory Affairs or GxP project management.
  • Strong knowledge of pharmacovigilance AE reporting systems and regulations required.


PERSONAL QUALITIES

  • Excellent interpersonal and communications skill.
  • Results oriented; effectively manages a multitude of projects efficiently.
  • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker.
  • Builds strong, effective working teams; builds relationships to share best practices, and solve shared problems.
  • Demonstrates in-depth understanding and application of cGxP principles, concepts, practices and standards in the Europe and internationally.


CONTACTS

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.


EQUIPMENT

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.


RECRUITERS

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.

 

 

Apply for this job: GxP Operations Manager

Contact Information:

Address:  Head Office
10 Bloomsbury Way 5th Floor London
WC1A 2SL
England
Tel:  44 (0)207-420-0800
Website:  Visit Our Web Site

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