Senior Lead Quality Specialist

2 weeks ago

Limerick, Limerick, Ireland beBeeQuality Full time €98,336 - €128,712

Quality Assurance Manager

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  • A Quality Assurance Manager will oversee the support operations and be responsible for maintaining oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning)
  • They will provide direction to Managers and staff that support the equipment and ensure equipment qualification and maintenance programs are aligned with regulatory agencies' requirements
  • The Manager will interact with QC partner groups to establish internal requirements for equipment and lead QC equipment validation/qualification efforts through partnering and interaction with QA Validation and IT groups
  • Responsibilities include managing oversight of the preventive and corrective maintenance monitoring program, QC external laboratories' activities and performance monitoring of external testing laboratories
  • The Manager will supervise the issuance and approval of Quality agreements and SLAs with the contract labs, verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization
  • Identifying and calling out issues at contract laboratories to QC leadership is also a responsibility
  • Sourcing, co-ordinating, and project management of GMP activities relating to new contract lab introduction may also be required
  • Travel may be necessary in support of external contract laboratory testing activities
  • The position requires performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations
">Required Skills and Qualifications
  • A Bachelor's or Master's degree in Chemistry, Biology, or related field is required
  • 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry is preferred
  • Previous supervisory or leadership experience is also required
">Benefits

We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

">Regeneron is an equal opportunity employer

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