Global Compliance Manager, GMP & Life Science - Moderna

Skills :     Account Manager

Job Description:

Equans is looking for a Global Compliance Manager, GMP & Life Science for Moderna!

The Equans group is a world leader in the energy and services industry. The Group operates in 20 countries, with 90,000 employees working on 5 continents. Equans is a Bouygues group company.

Equans designs, installs, and delivers customized solutions to improve its customers’ equipment, systems, and technical processes and optimize their use in the context of their energy, industrial and digital transitions. Equans is a Bouygues group company.

Active in Canada and the United States for more than 30 years, Equans Services is the partner of businesses, industries, and institutions that want to move towards more connected buildings, manage their facilities efficiently, and reduce their carbon footprint.

We design, implement, and maintain custom solutions to improve our customers’ facilities, systems, and infrastructures.

Our core offerings are focused on the following areas:

• Integrated Asset and facilities management;
• Operation and maintenance of buildings and equipment (including district heating and cooling);
• Energy efficiency solutions and execution of decarbonization roadmaps;
• Building automation and systems;

To learn more, visit www.equansservices.com/en

Summary

The Global Compliance Manager, Life Sciences is crucial in ensuring that each regional department's efforts contribute to the success of Equans' quality control, validation, and processes platform. This role involves assessing, managing, and improving various organizational processes for GMP/GxP Life Science to enhance efficiency, productivity, and growth and ultimately ensure contractual obligations are adhered to. They play a key role in promoting compliance, overseeing the use of Equans' quality platform tool, and fostering a culture of continuous improvement.

Description

Key Responsibilities:

• Enhance Process Development: Improve current methodologies and practices to meet industry best practices, establishing a world-class process development system. Write, revise, and develop continuous improvement documents, including SOPs, reference guides, and manuals.
• Promote Departmental Collaboration: Encourage cross-departmental communication and cooperation to ensure alignment with the Quality Platform goals.
• Ensure Quality Assurance: Uphold high standards of quality assurance and control throughout the process development lifecycle by working with quality assurance teams across departments to maintain consistency with overall quality objectives.
• Facilitate Cross-Functional Integration: Collaborate with departments such as Research and Development, Manufacturing, and Quality Assurance to incorporate contributions into the Quality Platform. Organize cross-functional meetings and initiatives to streamline processes and enhance quality outcomes.
• Develop Training Programs: Support the creation and implementation of a comprehensive training program for the process development team to ensure continuous improvement and skill enhancement. Work with Training and Development departments to utilize resources and expertise.
• Improve Contemporary Processes: Drive the enhancement and development of modern processes and systems to improve the quality platform's efficiency and effectiveness. Work with Research and Development to ensure new processes transition smoothly into development and production phases.
• Ensure Process Compliance: Collaborate with departments to ensure processes meet contractual requirements and industry standards. Provide expertise on process improvement based on regulatory inspections and audit findings.
• Support Audit Activities: Assist with corporate audit activities by collaborating with compliance groups on risk management processes. Work with managing departments to identify and mitigate risks associated with process development activities.
• Pursue Process Innovation: Identify and pursue opportunities for innovation in process development to drive quality improvement initiatives. Work with Innovation and Research departments to explore new technologies and methodologies for process optimization.
• Manage Failure Analysis: Oversee root cause failure analysis for significant process-related events and implement corrective actions to prevent recurrence. Work with relevant departments to comprehensively address root causes.

Requirements

• Is authorized to work in the US;
• Educational Background: Hold a degree in business administration or a related field from a four-year college or university, with over 10 years of relevant experience; or an equivalent combination of education and experience;
• Organizational Skills: Demonstrate strong organizational abilities;
• Results Orientation: Be results-driven and focused on achieving goals;
• Technical Proficiency: Possess a high level of technical expertise and capacity;

What Equans Offers You

• Health Insurance;
• Paid statutory holidays;
• Balance between work and personal life;
• Professional and personal development in a company experiencing strong growth;
• A positive working environment characterized by competence, responsibility, and innovation;
• Competitive terms of employment and excellent benefit schemes;

Equal employment opportunity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.

Comment

Does this challenge interest you? We would like to get to know you and we thank everyone who applies.