The Director of Compliance and Quality will support plant compliance with ISO, good manufacturing practices (cGMP), USP and other relevant standards. Position will manage the compliance with and documentation of government regulatory requirements. Monitor regulations (FDA and EPA) and implement necessary actions to ensure compliance. Support all aspects of product stewardship, identifying and minimizing the health, safety, environmental, and social impacts of a product throughout its lifecycle, while maximizing its economic benefits. It is a shared responsibility and a team effort, requiring the knowledge and expertise of a variety of disciplines, with the primary goal of minimizing product liability by ensuring compliance with all applicable laws governing the use of our products in all end-uses and jurisdictions in which our products are used.
- Ensure compliance with all relevant standards.
- Leads and oversees all aspects of product stewardship initiatives in all regions/countries where a BU’s products are used, supporting similar functions globally across all products in the Division.
- Provides functional leadership with respect to compliance and product stewardship for Filtration quality teams across North America.
- Understands and assesses product safety and regulatory issues. Provides coaching and guidance to Division representatives as appropriate. Interacts with all relevant stakeholders within or outside of the Division.
- Manages product stewardship needs associated with the entire supply chain including suppliers and distributors to foster product safety management and information exchange, commensurate with risk.
- Direct supervision of 1 ISO/Document Control Specialist located at the Lompoc site.
- Domestic travel required: 25%
- International travel required: 10%
KEY TASKS AND RESPONSIBILITIES
- Coordinate with Sr. Quality Manager to ensure Quality Management System (QMS) meets regulatory compliance guidelines.
- Handles customer requests regarding product safety and regulatory issues as well as information on Division’s product stewardship programs. Assists customers in understanding emerging and existing regulations and their relevance to our products. Interaction with customers may be direct or through sales, marketing, or technical support networks. Develops and maintains good relationship with key customers to enable their product acceptance processes and hazard communication programs.
- Support the plants in their efforts to comply with the current cGMPs
- Support plant managers to ensure procedures and policies are in-place to ensure USP-compliance.
- Ensure sampling plan and internal audit schedules are followed by plant managers to maintain FCC-compliance
- Works closely with product stewardship managers from the other Imerys Divisions to ensure consistency of the message across all businesses. Shares expertise, relevant data, and best practices in order to gain group efficiencies.
- Support plants in ISO recertification
- Coordinate with Group Product Stewardship Director to ensure Imerys strategy is implemented and followed across BU.
- Coordinate with global team to ensure compliance and product stewardship requirements are met across BU’s.
- Active as BU lead in Group Corporate Social Responsibility initiatives.
- Stay up to date on regulatory changes and maintain Imerys’ statements database regarding regulatory compliance.
- Act as liaison for EPA pesticide registration.
- Support commercial and legal teams with customers’ quality agreements and quality compliance component of commercial agreements. Ensure language is not counter to Imerys’ policies and procedures.
- Provide customer support for global product compliance.
- Manage on-site customer audits and ensure responses are timely and appropriate to allow customer compliance per their audit requirements.
- Manage supplier audit program to ensure all compliance and product stewardship needs are met.
- Ensure best practices in quality management and strive for continuous improvement
- Participate in major certification and customer audits ensuring that corrective action plans are completed as needed
- Coordinate with Sr. Manager – Quality and relevant managers on maintenance of operations SOP’s to ensure procedures in-place provide for full regulatory compliance.
- Manages document control for plant quality procedures
- Support NPD initiatives – Coordinate with Sr. Manager – Quality and relevant personnel to ensure new products and/or processes are in compliance with established standards.
EDUCATION AND/OR EXPERIENCE REQUIREMENTS:
- Bachelor of Science in Chemistry or related field. Master’s degree preferred.
- Minimum 6 years in Quality, EHS or production-related position(s) in industrial minerals industry
- Industry Certifications: ASQ, ISO, auditor certification.
- A minimum of 5 years’ experience in product stewardship, regulatory affairs, or advocacy in chemical or mineral industry in a large enterprise/cross-divisional company is preferred.
Knowledge, Skills, Abilities, and Attributes:
- Problem solving, analytical, team-building/leading
- In-depth knowledge of GHS, hazard communication standards, as well as knowledge of REACH and cosmetics, food, feed, pharma regulations is desired. A good grasp of global regulations as they apply to non-food, non-food/non-pharma and non-pesticide products is a plus.
- Strong communication and interpersonal skills needed to engage with global and regional business contacts, demonstrated ability to work well within a cross-functional, multi-division, virtual and matrixed business environment.
- Experience in acquiring regulatory knowledge and developing competency with respect to global
- Regulations governing chemical management, chemical hazard communication, chemical use, dangerous goods transportation, and banned or restricted substances.
- Ability to work well in cross-functional groups without direct management authority
- Broad flexibility to make decisions affecting product quality
- Consistency and ability to communicate clear rationale is critical
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