Quality Control Laboratory Process – System Manager

Role Overview

• Support Directions, impact analysis and implementation plan of global, regional initiatives and applicable regulations
• Understand the applicable compliance landscape, ensure active participation in the related community of practices, meetings and governance (i.e Compendia method)
• Deployment of Lab Strategy and Systems roadmap for the Quality labs
• Partner with R&D for E2E Test Method Life cycles, compliance update, Complex Lab investigations
• Participate in the regional Laboratory councils, COP and ensure active EMEA participation to global laboratory initiatives, councils, governance.
• Support the capability building in the region via deployment of the transformational programs and rapid adoption of best-in-class practices
• Transversal Lead a team of sites Lab Leaders & SMEs creating a community of practice for the region
• Support EMEA Lab related investment Budget proposal. Define Prioritization and ensure consistency with targets and execution.
• Govern implementation of defined Key Laboratory Performance Indicators (KPIs) under internal Lab responsibility, and strategic project milestones to monitor execution and identify key areas of risk or opportunity.
• Report findings to EMEA and Sites Q&C management for informed decision-making and strategic planning.
• Collaborate with laboratory personnel, quality assurance, technical teams, and regulatory affairs to support governance, technology, processes and ensure seamless improvements, standardization and consistent implementation across the Region
• Collaborate with Sites, Global and cross-functional partners to drive change management activities related to the process, and foster a change mindset to balance a rapid pace of implementing transformational change with the requirements to ensure compliance across the sites
• Collaborate with Digital and Global system teams that systems are identified for critical process in alignment with global solutions, and when implemented result in a measurable improvement in laboratory efficacy and efficiency.
• Support Quality excellence initiatives in identifying, and consistently executing continuous improvement initiatives incorporating best practices, feedback and industry advancements to optimize performance and compliance
• 20% domestic travel

Requirements

• Bachelor’s degree in chemical/physical sciences, Business or a related discipline.
• A minimum of 10 years of relevant business experience within pharmaceutical, medical device, cosmetics or similarly regulated field
• Significant experience in Quality Control Laboratories (and/or Analytical, Micro, Stability).
• Fluent in English (spoken and written)
• Demonstrated leadership & influencing skills across organizational levels
• Ability to handle high-pressure situations and make informed decisions quickly
• Excellent communication and interpersonal skills to collaborate with regional/local/cross-functional partners.
• Strong problem-solving and troubleshooting abilities
• Detail-oriented with a strong focus on quality and continuous improvement
• Strong Business and Financial Acumen

Benefits

• Competitive Benefit Package
• Paid Company Holidays
• Paid Vacation
• Volunteer Time
• Summer Fridays & More!
• Extensive Learning & Development Opportunities
• Employee Resource Groups