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Quality Manager/Site GMP Auditor (Associate Director) - Ireland  

MSD (company)


Posted on : 09 June 2017

Project Description

  • Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.  
  • Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  •  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  
  • As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
  • The Quality Manager/GMP Site Auditor (Associate Director) will have the unique opportunity to work across Development, Clinical and Commercial activities for API and Drug Product businesses.

Key responsibilities will include:
  • Lead scheduling and tracking of Quality System Audits and GMP Walk Downs in accordance with approved Audit plans for the site
  •  Lead site GMP audits in accordance with approved procedures and applicable standards and regulations
  •  Lead the development and implementation of CAPA following audit program completion
  •  Lead the compilation of quality metrics related to audits for dissemination at Quality Council and Management Review
  •  Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards
  •  Lead in company and site preparations for support of regulatory and customer inspections
  •  Provide compliance advice to development and commercial product teams
  •  Supports and continually enhances the ongoing site Permanent Inspection Readiness status
  •  Lead training/orientation for new Quality Auditing staff
  • Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance- Lead effective change management for Audit CAPA delivery
  •  Lead resolution of Supplier Quality issues to assure compliance and a flow of high Quality materials
  •  Reports to the site Quality Director and participates as part of the site Quality Leadership Team

  • Minimum of 7 years Pharmaceutical industry experience within a GMP environment
  •  Extensive knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements
  • Extensive experience in GMP auditing across multiple Quality Management systems in API and/or Drug Product
  • Experience in GMP auditing of Computerised System, Supplier Management and Logistics/Warehousing
  • Experience working directly with regulators in audit situations
  • Ability to build relationships and influence across disciplines and all levels
  • Should be highly motivated, flexible, and have excellent organisational and communication skills
  • Excellent verbal and written communication skills
  • Ability to prioritize and balance work from multiple projects in parallel

Travel: Yes, 5 % of the Time

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