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Europe Director for Regulatory Compliance and Quality Assurance
2 mesi fa
Please consider applying for this role in English, as applications in other languages will be rejected. Geiger Food Ingredients Recruitment & Consult is recruiting a Director for Regulatory Compliance, Quality Assurance Flavours and Food Ingredients for an international Flavours and Food Ingredients company. The position is remote and based in Europe.
Job Purpose:
- This role involves defining strategy and taking a proactive leadership to coordinate all strategic and operational activity on Regulatory and Quality at Group level.
- The purpose of this role is to define, align and implement Group standard policies, procedures, and practices to ensure that the company operates with a global approach in accordance with applicable laws, regulations, and quality standards.
- By effectively managing compliance and risk, the candidate will leverage regulatory and quality strategies to actively contribute to business development by helping the company to gain a competitive edge, expand into new markets, enhance customer satisfaction while optimizing operational efficiency.
- The candidate's role will be also crucial to assist the Group in deploying a PLM System (HAZEX/DEVEX) to standardize our Product Information, drive standardization process for Raw Material, product development processes, inter-company authorization flows, shared documentation repository.
Identifying opportunities and threats in the regulatory landscapes and support the group on this topic in the Mergers and Acquisitions.
Quality Assurance:
Drive standardization, centralization and digitalization of the Quality Assurance activities carried out by the group's local teams, with a particular attention to organizational and operational synergies on Quality management Systems compliance, Auditing and continuous improvement.
TasksKey Responsibilities:
- Standardize Group approach and set, implement, oversee global regulatory and quality strategy, with attention to organizational and operational synergies and cost optimization.
- Continuously monitor and interpret changes in regulations, standards, and industry guidelines to ensure the organization remains compliant with global regulatory requirements in alignment with corporate goals.
- Oversee the creation, maintenance, and submission of regulatory documentation required for product approvals, licenses, and certifications including plants audits.
- In line with the business strategy, set and implement the overall Regulatory and Quality mission and strategy.
Auditing:
Oversee internal audits and assessments activity.
Regulatory Affairs Support:
Collaborate with product development teams to navigate regulatory pathways, streamline approvals, and expedite product launches.
- Proactively identify regulatory risks to company's programs and develop risk mitigation plans creating a process for identifying, and quickly remediating risks and/or compliance concerns/issues.
- In line with the corporate goals, define, develop, and manage Global Regulatory Affairs and QA Requirements.
- Minimum of 15 years of chemical/biotech/pharmaceutical leadership, with a proven leadership to design and build from scratch a global Regulatory and Quality organization needed to achieve company objectives (direct experience on Flavours and Colours regulatory legislation will be a plus).
- Proven knowledge of PLM systems to manage Regulatory and Product Development in the chemical or food industry, especially Hazex/Devex systems.
- Broad and deep regulatory agency knowledge and experience interpreting and guiding application of global regulatory requirements across multiple sites; Extensive exposure with multiple regulatory agencies.
- Ability to build and maintain effective internal and external relationships, including with local cross-functional teams, individual contractors, contract research organizations, external associations and other vendors to effectively manage all legal, regulatory and quality related activities.
- Proven ability to analyse complex issues to quickly address key issues for discussion with regulatory authorities and guide teams (internally/externally) in the preparation of responses to regulatory questions.
- Demonstrated and extensive hands-on attitude on the field to deliver goals.
- Team builder able to engage local Quality, Regulatory departments to encourage collaboration.
- Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities.
- Fluent in English, French or Italian is a plus.
- Ability to travel up at 50%.