MSD Lab Ops Stability & Compliance Lead 

Ireland, Cork 

876777131

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.