Associate Manager Quality Compliance

4 weeks ago

Dublin, Dublin City, Ireland GrabJobs Full time
Job summaryAssociate Manager Quality Compliance position Facilitating activities and relationships regarding External Manufacturing change controls Lead and manage direct reports, work to develop and oversee their performance and growth Job seniority: mid-to-senior level Responsibilities

  • Meeting with External Manufacturing department to discuss changes for applicable products
  • Maintaining internal databases and tracking of change notifications
  • Partnering with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Process and associated procedures
  • Developing relationships with end users and providing advice on best practices/ strategy for changes that require partner notification
  • Developing, monitoring, and communicating metrics to ensure the health of the partner notification process
  • Partnering with counterparts to ensure global alignment of processes, systems, and procedures
  • Partnering with colleagues in other departments on strategies to ensure changes do not impact supply
  • Assisting as needed in audits and inspections
  • Review and Approval of Change Proposals as required Requirements
  • Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
  • Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another
  • Aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment
  • Proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
  • Possess excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships
  • Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems heavily preferred
  • Bachelor's in a scientific or engineering discipline or related field with 8+ years experience in a combination of Quality, Production, Engineering, Regulatory (Chemistry, Manufacturing and Control) and/or Laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements
  • Experience in change control function strongly preferred Key Skills Needed
  • Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
  • Ability to perform independent work requiring attention to detail, accuracy and scientific judgment
  • Excellent interpersonal, written and oral communication skills
  • Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint

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