Quality Control Operations Manager

2 weeks ago

Limerick, Limerick, Ireland beBeeQuality Full time €100,000 - €140,000
Job Overview:

This is a leadership position responsible for overseeing quality control support operations and ensuring equipment qualification and maintenance programs meet regulatory requirements.

The successful candidate will oversee the lifecycle of QC equipment, including procurement, installation, qualification, maintenance, and decommissioning, while providing direction to staff supporting equipment and managing preventive and corrective maintenance monitoring programs.

They will lead QC equipment validation/qualification efforts through partnering with QA Validation and IT groups, manage oversight of external laboratories' activities, and performance monitoring.

This role requires supervising the issuance and approval of Quality agreements and SLAs with contract labs, verifying site Manufacturing licence and global procedures reflect current contract lab utilization, identifying and addressing issues at contract laboratories, and sourcing, coordinating, and project-managing GMP activities relating to new contract lab introduction.

The ideal candidate will have strong communication and interpersonal skills, logical troubleshooting and problem-solving skills, a detailed understanding of equipment qualification and maintenance activities and industry compliance norms, ability to communicate effectively with multiple partners, enjoy working in a fast-paced environment, and possess a collaborative and team-orientated approach.

A Bachelor's or Master's degree in chemistry, biology, or related field is required, as well as 8+ years of experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience.

Key Responsibilities:
  • Oversight of QC equipment lifecycle activities
  • Management of preventive and corrective maintenance monitoring programs
  • Leadership of QC equipment validation/qualification efforts
  • Supervision of Quality agreements and SLAs with contract labs
  • Identification and addressing of issues at contract laboratories
Requirements:

Strong Communication Skills: Ability to effectively communicate with multiple partners, including staff, management, and external stakeholders.

Problem-Solving Skills: Ability to analyze complex problems and develop effective solutions.

Industry Knowledge: Detailed understanding of equipment qualification and maintenance activities and industry compliance norms.

Benefits:

Competitive salary and benefits package.

Opportunity to work in a dynamic and fast-paced environment.

Chance to grow professionally and take on new challenges.

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