HSEQ & Regulatory Affairs Director

IMCD Group B.V.

10d•$110,000 - $150,000

About The Position

HSEQ & Regulatory Affairs Director Ready to Make an Impact? As a leading specialty chemicals distribution partner, IMCD has an important role to play in society, including by protecting health and welfare, improving economic prosperity and helping to create a more sustainable future. IMCD operates as a professional services business where highly qualified key people working together in a flat organizational structure are making a real difference. By joining IMCD, you’ll be part of an entrepreneurial, fast-growing group of ambitious and like-minded professionals, where you’ll have the freedom to make your own mark. IMCD is proud of its people and culture and considers them to be its most valuable asset by far! Do you want to work for a growing and expertise-driven company? Then we’d love to hear from you! About IMCD IMCD is a leading global distributor and formulator of specialty chemicals and food ingredients, headquartered in Rotterdam, the Netherlands. Since our founding in 1995, our entrepreneurial spirit has driven smart, sustainable solutions powered by local know-how and global expertise. Publicly listed on Euronext Amsterdam (AEX), IMCD operates across EMEA, Asia-Pacific, and the Americas. We partner with top-tier suppliers to deliver tailored solutions across eight business groups, including Beauty & Personal Care, Home Care and Industrial & Institutional Cleaning Solutions, Food & Nutrition, Advanced Materials, Coatings & Construction, Lubricants & Energy, and Industrial Solutions, and Pharmaceuticals. IMCD’s strength lies in its dual focus on distribution and formulation. Through our global network of technical and commercial experts, we collaborate closely with customers to develop impactful, innovative solutions that shape industries and meet the evolving needs of the markets we serve Job Purpose Oversee the daily operation of the Quality, Regulatory and Safety team who are involved in the monitoring, controlling, and improvement of quality and safety systems; providing assistance to marketing, sales, and warehouse staff in product regulatory matters, and managing corporate risk regarding environmental, health and safety, and regulatory. Responsible for ensuring that the HSEQR Department is meeting the Canadian and US Health, Safety and Environment requirements for importation, handling, transporting, and sale and use of our products. Including monitoring and any annual reporting and government required submission to ensure compliance with the Canadian & US Laws Health and Safety and Environment regulation requirements. Ensuring compliance and support with GFSI FSSC 22000, ISO9001, ISO14001, RDC, RSPO, FSMA, FSVP, Safe Foods and Pharma GMP standards, Licenses and policies. A primary role for this position is to ensure that the company complies with GMP as they apply to an importer holding a drug and/or API DEL (Drug Establishment License), in accordance with the Health Canada regulations. This role is the primary Company liaison with Health Canada relating to import regulations.

Requirements

Degree in a chemical-related discipline, preferably with a Bachelor Sc. or Engineering and an emphasis in Quality.
Ten years direct experience involving quality assurance, compliance with applicable regulatory requirements in a food and/or pharmaceutical regulatory position. Hands on experience in document control, and quality systems as well as auditing.
Strong working knowledge of GMP requirements and regulations that apply to pharmaceuticals.
Good understanding of GMPs, AIB, HACCP, Food and Drug Regulations, WHMIS, TDG, GFSI
Excellent organizational skills, ability to plan and prioritize, meet deadlines
Clear verbal and written communication skills are required. This position will be required to act as the Company liaison with government agencies ( Health Canada)
Demonstrated experience in handling regulatory inspections.
Computer literacy
Experience leading, collaborating, and motivating cross-functional and diverse teams in both matrix and non-matrix organization, in a way that is mutually beneficial and drives continuous improvement.
Know how to define KPI and steer teams and stakeholders into the right direction.
Knowledge of the chemical regulatory field (GHS, REACH, TSCA etc), a bonus is the additional knowledge of food/feed and pharma legislations.
Basic understanding of IT systems (MS office, ERP systems, SQRL and data analysis).
Able to apply process thinking and to create clarity from datamining.
Strong leadership skills
Persuasive and a team player
Ability to remotely influence others
Strong customer focus, both internally and externally
Attention to detail and process
“Get it right” mentality
Ability to complete to deadlines

Nice To Haves

French language skills a definite asset.

Responsibilities

Provide leadership to HSEQ & Regulatory country managers and communicate the company's vision, direction, goals, performance against plan, changes, and expectations to achieve IMCD strategic business goals. Liaise with other regional HSEQ & Regulatory directors monthly on pending issues.
Be aware of change management processes within business units and the impact and risk to the business. Utilize risk mitigation tools to assess the risk and take appropriate measures, whilst maintaining excellent relationships and developing collaborative workflows working with various stakeholders at all levels of management to support HSEQ & Regulatory objectives and a shift in culture where required.
Partner and collaborate with all regional Operation directors/managers to influence and manage HSEQ & Regulatory resources, projects, and business decisions.
Be a key stakeholder in evaluating future IMCD acquisitions and/or integrations performing risk assessments and mitigation to ensure full HSEQ & Regulatory compliance in all disciplines such that global directives are implemented, and product risk assessments are conducted.
Drive EHS and QMS performance by providing necessary resources and holding the country managers accountable to complying with all global, regional and local programs, policies, and requirements.
Analyze and identify trends on key compliance parameters to ensure risk mitigation and certification creation for products and local HSEQ & Regulatory performance taking into account Key Stakeholders and Interested Parties.
Manage product approval issues and data integrity within the IMCD platforms.
Support environmental compliance and achieve all environmental goals driving to meet sustainability objectives.
Understands both the economic and cultural value that a safe organization meeting all compliance requirements with minimal environmental impact brings to an organization.
Be up to date with current and future regulations and ensure the business, regional and local levels, are prepared to meet them.
Oversight of Company regulated product procedure manual as necessary to ensure GMP compliance
Keep current on legislation and regulatory requirements, as they relate to regulated product import activities. Communicate potential impacts of new legislation or regulatory requirements to Company.
Development and implementation of multiple standard documentation requirements which include, but are not limited to GFSI, ISO, RDC, RSPO, FSMA, FSVP, and Safe Foods standards and policies.
Responsible for ensuring that the environmental management system (EMS) conforms to the requirements of the ISO 14001 Standard.
Responsible for reporting on the performance of the EMS, including environmental KPIs to SLT.
Review master documentation provided to Company. Identify any deficiencies and work with foreign manufacturers to address.
Review all Company regulated product imports to ensure GMP compliance. Compare product data obtained from foreign sites. Investigate any discrepancies and once all issues have been resolved, sign off on release of product to remove it from quarantine and allow Company to distribute product.
Review all Company regulated product complaints in conjunction with the team, and authorize closure of any complaints.
Responsible for oversight and managing the Company recall process for any regulated products imported into Canada
Assist with annual application / renewal of Health Canada site licenses.
Conduct regular self-inspections of the Company warehouses to ensure GMP compliance.
Oversight of annual product reviews and trending.
Provide GMP compliance and SOP training to Company staff members
Act as primary contact during Health Canada inspections.
Review and authorize final disposition for non-conforming material including returned finished goods received from customers
Create and update New Product Assessments and other technical documents, as assigned.
Report on process performance as required.
Lead the Quality, Safety & Regulatory Affairs group, providing clearly defined goals, objectives with frequent monitoring of progress. Work with the team to provide a visible and credible department to internal and external clients.
Implement monitor and control our quality systems, concentrating on methods which will improve company efficiency and profitability, and performing such work within ISO document standards. Perform ongoing review of quality systems and procedures in order to identify and recommend revisions to current ISO, AIB, Responsible Distribution compliance systems and assist with the implementation of new systems. Recommend and implement changes or new systems which are consistently applied across all operations.
Develop and implement plans with the Management Safety Team to address incidents, promote safety, and improve health and safety at all facilities
Lead the investigation of non-conformances and corrective action requests.
Manage and provide oversight on the IMCD recall process working with all departments including liaising with the legal department and Senior Leadership providing accurate information on the impact of any potential or physical recall.
Maintain food safety and total quality systems and tools to measure, track, and improve performance and efficiency. Communicate with all segments of the organization to act as a resource to provide tools to measure performance, methods, and approaches to develop and improve efficiencies.
Maintain and update quality problem reports and ensure action is being taken in a timely manner. Close request when action is complete. Maintain files and records as required.
Lead the operations committee meeting and prepare quality summary reports for the management committee.
Coordinate schedules and meetings for external and internal audits while creating and maintaining awareness of the ISO 9001, ISO14001, FSSC 22000, AIB and Responsible Distribution quality standards throughout the organization.
Coordinate food and drug submissions and customer/supplier support in developing the market.
Other projects as assigned.

Benefits

Comprehensive group benefits
Flexible work schedules
A collaborative, innovative environment that encourages freedom to act and an entrepreneurial spirit

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume