Director Of Quality & Regulatory Europe

Actylis is a leading manufacturer and supplier of critical raw materials and performance ingredients serving the Life Sciences, Specialty Chemicals, and Agriscience industries.
We offer standard and custom ingredients through our rapidly growing portfolio of GMP and non-GMP facilities worldwide, and further choice through our strong sourcing hub network. This unique hybrid option blending manufacturing and global sourcing, combined with more than 75 years of sourcing and distribution experience makes Actylis the Partner of Choice.
Position Summary
The Director of Quality and Regulatory Europe oversees the quality assurance and quality control teams as well as the Quality Management System (QMS) and regulatory personnel. Responsible for managing all aspects of Quality and regulatory compliance for the company’s operations in Europe, ensuring adherence to relevant standards, regulations, and customer requirements. In this capacity, serves as the representative of EU Quality within Global Quality Unit to ensure the consistent adoption and enforcement of best practices. This role demands a high level of autonomy, strong organisational skills, and effective communication, both internally within the company and externally with customers.
Responsibilities will include:

• Ensures Quality and Regulatory compliance across all European Business Units, including Specialty Chemicals, Pharmaceutical Intermediates, Cosmetics, Nutrition, Active Pharmaceutical Ingredients, Bio Pharma Intermediates.
• Provides guidance to Quality Assurance Teams as well as regulatory and QMS teams.
• Supports teams in expert, manager, and collaborator roles.
• Develops the European strategy for Quality and Regulatory in alignment with Global Quality Unit
• Designs and implements processes throughout the organization.
• Deploys tools in accordance with the strategy of Global Quality Unit
• Ensures that Quality and Regulatory performance meets established criteria.
• Plays a key role in global and regional projects related to Quality and Regulatory aspects.
• Represents Quality and Regulatory as a member of the European Leadership Team
• Ensures the application and execution of Quality Management System (QMS) in place. Page 2 of 2
• Holds ultimate responsibility for a harmonized QMS in Europe, including any locally adapted versions (e.g.GMP, GDP, cosmetics, HACCP etc.).
  

Required Experience & Knowledge

• Scientific background in Biology, Chemistry, Biochemistry or Biotechnology
• Approximatively 10 years of relevant experience in working with Quality Management Systems, including Quality Assurance and Quality Control
• Proficiency in Knowledge of relevant guidelines and norms
• Strong Project Management skills
• Autonomous and driven leadership position
• Proficient in Team management
• Capable of performing complex tasks and establishing processes
• Strong problem-solving skills
• Experienced in collaborating with colleagues from diverse cultural backgrounds in a global environment.
• Fluent in English, proficiency in other languages (German, Dutch, French) is a plus.
• Self-motivated and self-directed
• Excellent interpersonal relationship skills
  

Physical Demand
Supervisory Responsibilities

• Oversees all quality and regulatory teams at Actylis Europe
• Directly supervises Senior Quality Manager role employees.
• Set goals and objectives for the quality and regulatory organization at Actylis Europe
• Reviews performance and identifies opportunities for improvement within the quality organization.
  

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made where necessary. The noise level in the work environment is usually moderate. Office-based utilizing the companies’ office space or home based; the position requires a high level of travel, for internal meetings with team members or with customers.