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Manager, GxP Audit - Ireland  

Company managed [?] Still accepting applications

Posted on : 12 June 2017

Project Description

Description:
  • Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. 
  • Our company  developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. 
  • Our company  is also establishing a premier global metabolic rare disease franchise.
  • In addition,our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas. As the global leader in complement inhibition, the Company is strengthening and broadening its portfolio of complement inhibitors across diverse platforms, including evaluating potential indications for Soliris in additional severe and ultra-rare disorders. 

 

Position Summary
The Manager GxP Audit will be responsible for assisting in the development, implementation and maintenance of the company  risk based GxP Audit programme. The successful candidate will assist in the monitoring of company’s internal global operations and vendors, to ensure compliance with company requirements and applicable GxP regulations. The candidate will have extensive experience in GxP areas and must have the ability to function in a matrix environment.

 

  • Schedule, prepare and monitor global company and vendor GxP audits in collaboration with audit team as per plan.
  • Participate in the audit needs assessment & risk assessment process.
  • Support the audit planning, preparation and follow-up process.
  • Analyse audit outcomes for trends and risks and communicate to Senior Management.
  • Collect and report performance metrics.
  • Escalate critical findings to management.
  • Review audit report responses/ CAPA plans for appropriateness.
  • Represent the company GxP Audit function in Regulatory Inspections.
  • Assist with Inspection Readiness as requested.
  • Effectively liaise with Quality leaders and other key stakeholders on coordination and communication of the audit and inspection readiness activities.
  • Monitor HA Inspection findings externally for trends/ hot topics that are recurring and implement actions to address internally as necessary.
  • Maintain supporting procedures and processes.

 

Qualification
  • 7 years+ experience in Quality Assurance or Compliance Management related role, with strong Quality Management Systems knowledge
  • Demonstrable project management skills; experience working in cross-functional teams.
  • Experience in Internal/Vendor Audits an advantage
  • Strong Business Partner with a focus on collaboration and delivering results.
  • Thorough knowledge of applicable international GXP regulations and standards (e.g., GMP, GDP, GLP, GPV etc.).
  • Ability to influence management, peers and other colleagues without direct reporting lines.
  • Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
  • Ability to multi-task and prioritize work
  • Strong organizational ability
  • Demonstrable computer skills
  • International Travel approx. 20%



Education
  • Bachelor's Degree in physical /life science or pharmacy; Advanced degree preferred, but not required.



About Us: 
  • Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company  developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.  
  • As the global leader in complement inhibition, our company  is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.  
  • Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders 
  •  In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas