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Global Complaince Manager , GMP & Life Science

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EQUANS

2mo ago

  • Job
    Full-time
    Expert Level
  • Business, Operations & Strategy
    Legal
  • Boston

AI generated summary

  • You must have US work authorization, a relevant degree with 10+ years of experience, strong organizational skills, results-driven focus, and excellent knowledge of GMP and the pharmaceutical industry.
  • You will enhance process development, promote collaboration, ensure quality assurance, facilitate integration, develop training, improve processes, ensure compliance, support audits, drive innovation, manage failure analysis, and maintain leadership relationships.

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;
  • Excellent Pharmaceutical industry and GMP process knowledge is a must.

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.
  • Maintain Leadership Relationships: Develop strong relationships with organizational leaders to effectively address quality and compliance-related issues. Serve as a liaison between the process development team and other departments to ensure alignment with overall business objectives.

FAQs

What is the job title for this position?

The job title is Global Compliance Manager, GMP & Life Science.

What are the key responsibilities of the Global Compliance Manager?

The key responsibilities include enhancing process development, promoting departmental collaboration, ensuring quality assurance, facilitating cross-functional integration, developing training programs, improving contemporary processes, ensuring process compliance, supporting audit activities, pursuing process innovation, managing failure analysis, and maintaining leadership relationships.

What qualifications are required for this position?

Candidates must be authorized to work in the US and 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. Strong organizational skills, results orientation, technical proficiency, and extensive knowledge of the pharmaceutical industry and GMP processes are also required.

Where is this position based?

This position is based in Boston, United States.

What does Equans offer to its employees?

Equans offers health insurance, paid statutory holidays, a balance between work and personal life, professional and personal development opportunities, a positive working environment, competitive terms of employment, excellent benefit schemes, and a diverse workplace that values inclusion.

Is there an emphasis on diversity in the workplace?

Yes, Equans believes in the importance of diversity and inclusion, promoting a workplace that values diverse gender, age, and cultural backgrounds.

How can candidates apply for this position?

Interested candidates can apply for this job offer through the application process provided by Equans, as mentioned in the job listing.

What is the overall goal for the Global Compliance Manager in this role?

The overall goal is to ensure that each regional department's efforts contribute to Equans' quality control, validation, and process platform, enhancing efficiency, productivity, and growth while ensuring compliance with contractual obligations.

What kind of experience is relevant for this role?

Relevant experience includes significant exposure to quality control, GMP/GxP practices within the life sciences sector, and leadership experience, particularly in process development and compliance management.

Will the Global Compliance Manager work with other departments?

Yes, the role requires collaboration with various departments such as Research and Development, Manufacturing, and Quality Assurance to ensure comprehensive process integration and adherence to quality standards.

EQUANS

Engineering & Construction
Industry
10,001+
Employees

Mission & Purpose

Equans, a Bouygues group company, is the world leader in multi-technical services with offices in 20 country hubs. This brand expresses the desire to provide the right answer [ANS] to the equations [EQU] of our customers. We design and provide customised solutions to improve our customers’ buildings, technical equipment, systems and processes and to support them in optimising their use. With nearly 95,000 highly qualified employees and a strong geographic footprint through our historical local brands, we have excellent technical know-how in design, installation, maintenance and performance services, with a unique combination of skills as in HVAC, Cooling & Fire protection, Facility Management, Digital & ICT, Electrical, Mechanical & Robotics...Equans expertise and knowledge of our customers’ businesses now place us to support them in their transitions for modernisation and sustainable development.