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MSD Lab Ops Stability & Compliance Lead 
Ireland, Cork 
876777131

30.06.2024

Job Description

Responsibilities:

  • Manage the stability program on site and collaborate with other sites within the network to deliver a seamless stability program
  • Ensure that all Stability Equipment is maintained to the appropriate standards through established processes
  • Manage the Stability & Compliance Team
  • Partner and provide oversight for Contract Labs
  • Participate in and comply with our Manufacturing Division Quality Management System (QMS) requirements
  • Maintain and improve MPS goals and Model area within the stability team
  • Conduct variance investigations, management, and resolution
  • Coordinate the allocation of resources within the area to deliver a quality and efficient support service
  • Develop and provide succession planning for area personnel
  • Ensure the delivery of area performance to meet or exceed performance and quality metrics
  • Control area expenditure within budgetary limits
  • Contribute to site management operational and strategic initiatives
  • Ensure compliance with cGMP and other business compliance regulations
  • Establish SHE Objectives for the department and allocate adequate resources for their accomplishment
  • Participate in risk assessments, inspections, audits, incident investigations, etc., and implement related action plans

Requirements:

  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation
  • At least 5 years of experience in the pharmaceutical industry or a similar operating environment, including significant leadership roles and front-line supervisory experience
  • Strong compliance/quality background
  • Demonstrated leadership and change management skills with a continuous improvement focus
  • Degree or 3rd level qualification (Science/Quality) required; a master's degree is preferred
  • Project Management qualification such as Project Management Professional is desirable
  • Evidence of Continuous Professional Development is desirable
  • Lean Six Sigma Green Belt certification is preferred
  • Strong leadership, technical, problem-solving, and communication skills
  • Scientific qualification and relevant experience in pharmaceutical laboratory management

Behaviors:

  • Customer-focused, with a dedication to meeting customer needs, including patients
  • Collaborative, actively seeking differing perspectives and working together to achieve common goals
  • Candid and courageous, speaking openly and honestly, taking risks, and making difficult decisions
  • Capable of making rapid, disciplined decisions, supported by appropriate data
  • Results-driven, setting clear performance standards, overcoming obstacles, and holding self and others accountable
  • Ethical and demonstrates integrity, adhering to the highest standards of behavior and compliance with ethical guidelines and regulations
  • Skilled in talent development, building diverse talent and supporting individuals to reach their potential

Current Contingent Workers apply


Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.



Job Posting End Date:07/06/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.