Leading Quality Manager for Global Operations
4 semanas atrás
About Hovione
Hovione is an independent family-owned international group of companies, renowned for its innovative technological and productive capabilities. As a Contract Development and Manufacturing Company, we help Pharmaceutical Customers bring new and off-patent drugs to market.
Our diverse team of over 1,950 members from 36 nationalities, located across Asia, Europe, and North America, drives our continued success. With four production sites, we strive for innovation and excellence in everything we do: for our clients, partners, and patients.
We are In it for life, dedicated to delivering high-quality compliant sites through rigorous and continuous improvement culture. Our active communication channels ensure that all stakeholders are aligned and motivated towards achieving our goals, values, and culture.
Job Overview
We seek a highly skilled Quality Senior Manager to lead our quality efforts globally. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and project management.
The successful candidate will be responsible for implementing and managing quality systems, maintaining effective communication channels, and ensuring compliance with global and local regulatory requirements.
Main Responsibilities
- Implement quality systems, tools, and methodologies to guarantee high-quality compliant sites
- Maintain active and efficient communication channels along multiple Hovione sites
- Evaluate, advise, and provide services related to regulatory requirements
- Represent Hovione in communications and negotiations with regulatory authorities
- Ensure the implementation of a Quality system (Project VMP, URSs, SOPs adoption, Q&V, Site Master File, QC)
- Participate in Conceptual, Basic, and Detailed design reviews to assure GMP Compliance
- Assure the application of QRM tools and methodologies for new standards
- Provide regulatory counseling during project implementation
- Review documentation and represent quality in discussions with regulatory bodies
- Prepare and host regulatory inspections
- Evaluate area resources needs and maintain efficient communication channels
- Promote risk-based approaches and coordinate TM activities
- Develop and propose activity plans and budgets for the Area under responsibility
- Monitor Communications budget and take corrective measures
- Ensure compliance with GMP and HSE guidelines and promote policy implementation
Requirements
We require a Masters' degree in Chemistry, Chemical, Mechanical, or Electrical Engineering, or a related field. Technical background preferred. LEAN 6Sigma Green Belt certification preferred.
A minimum of 10 years of relevant experience is required, preferably in an operational area such as installation, qualification, or maintenance of Facilities and Equipment and/or Quality Assurance. Proven experience in leading others in project contexts is essential.
Effective time management skills and the ability to multitask are necessary. A track record of overachieving targets is desired. Extensive knowledge of Facilities and Equipment Qualification & Validation, cGMP, and Data Integrity principles and practices is required.
Fluency in English is a requirement, and the ability to effectively share knowledge with others is essential.
Salary Estimate: $120,000 - $150,000 per year, depending on qualifications and experience
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