Quality Control Laboratory Process & System Manager overseeing lab compliance and quality for EMEA sites. Guiding teams and implementing change initiatives for internal manufacturing operations.
Responsibilities
The Quality Control Laboratory Process and System Manager is the EMEA contact for the requirements and processes related to laboratory Process and System.
This individual is responsible for providing guidance for Quality Lab Controls, Systems and Compliance Requirements applicable to the regional operations at EMEA internal manufacturing sites, and for supporting performance, and improvement & compliance initiatives.
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.
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
Paid Company Holidays
Paid Vacation
Volunteer Time
Summer Fridays & More!
Job title
Quality Control Laboratory Process – System Manager
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