BARENTZ NORTH AMERICA LLC
The Regulatory / Quality Manager serves as the primary technical expert and strategic leader for regulatory compliance and quality assurance across the Pharmaceutical division at Barentz North America. This division manages a diverse portfolio of globally sourced excipients sold into regulated markets, including pharmaceutical, biopharmaceutical, and nutraceutical sectors. This role is responsible for designing, implementing, and maintaining robust regulatory and quality systems that ensure full compliance with applicable North American and international regulations and standards (e.g., EXCiPACT, IPEC-PQG GMP/GDP). The position oversees supplier and product qualification, document control, audit readiness, quality systems, and customer support, ensuring that compliance frameworks are integrated into daily operations. The ideal candidate is a proactive, detail-oriented professional with strong communication and organizational skills who can effectively translate complex regulatory requirements into actionable processes that support the business goals.
Essential Duties and Responsibilities*
Regulatory Compliance Leadership
Ensure that the division and product portfolio comply with all applicable regulatory agencies (e.g., FDA, Health Canada, EPA, DOT) and industry standards (e.g., EU GDP for excipients, IPC-PQG GMP, EXCiPACT, USP ). Interpret and communicate the evolving regulatory requirements for excipients and related materials, outlining their business impacts to internal stakeholders and customers. Manage and maintain regulatory documentation, including Safety Data Sheets (SDSs), regulatory and technical questionnaires, and various certificates such as TSE/BSE, GMO, allergen, residual solvents, elemental impurities, DMF references, and Kosher/Halal certifications, as well as REACH compliance and others. Prepare and manage documentation for customer audits and regulatory inquiries, including Quality Statements and Regulatory Summaries. Product and Supplier Qualification and Oversight
Conduct regulatory and quality evaluations for both new and existing products and suppliers to ensure compliance before their commercial introduction. This process includes reviewing chemical regulations, import/export codes, technical dossiers, risk assessments, aligning quality agreements, and assessing end-use regulatory requirements. Coordinate cross-functional review and approval of product documentation (e.g., CoAs, specifications, safety data sheets, GMP statements) to ensure compliance with industry standards and customer requirements. Assess the regulatory acceptability of materials for target markets such as pharmaceuticals, biopharmaceuticals, and nutraceuticals. This includes evaluating DMF references, ensuring compliance with relevant pharmacopeias (e.g., USP, Ph. Eur.), and identifying any pertinent import/export restrictions. Evaluate and oversee excipient manufacturers, distributors, and brokers through documentation reviews, risk assessments, and audits as necessary. Manage supplier qualification and ongoing monitoring processes, including the review of certifications such as EXCiPACT and ISO, as well as third-party audits. Maintain the Approved Supplier List and conduct ongoing risk assessments of excipients, considering supplier performance, material criticality, and intended use according to the IPEC risk evaluation framework. Quality Systems Management
Lead the implementation, maintenance, and continuous improvement of the QMS by incorporating principles from ISO 9001, EXCiPACT GMP/GDP, IPEC guidelines, and Responsible Distribution. Coordinate internal and external audits, ensuring audit readiness and documentation availability. Oversee document control processes, including critical records, such as SOPs, product specifications, CoAs, CoCs, and change notifications. Manage and track quality events, including deviations, complaints, and change controls, ensuring timely root cause analysis and CAPA implementation. Maintain and enhance Quality Agreements with suppliers and customers. Support recall and traceability efforts as needed. Champion continuous improvements by establishing risk-based quality controls in partnership with operations, supply chain, and commercial teams. Customer Regulatory Support & Product Compliance Guidance
Act as the primary regulatory/quality liaison for pharmaceutical, biopharmaceutical, and nutraceutical customers. Provide prompt support and responses for product inquiries, audits, compliance documentation, product traceability, certificates, regulatory declarations, and technical questionnaires. Collaborate with Operations, Sales, and Commercial Teams to ensure regulatory alignment during onboarding of products, suppliers, and customers. Proactively and clearly communicate important regulatory changes to internal stakeholders and customers. Training & Continuous Improvement
Design and deliver internal training on essential regulatory topics, including GDP, IPEC-PQG GMP, and document management. Provide continuous education to cross-functional teams on current regulatory requirements, quality standards, and compliance expectations to ensure alignment and awareness across the organization. Lead initiatives to support quality process improvement, reduce compliance risks, and enhance overall system efficiency. Monitor and report on key performance indicators (KPIs) related to quality and compliance, and engage in regular quality and risk management reviews to promote data-driven decision-making and improvement strategies. Team & Performance Management
Supervise and mentor Regulatory Specialist within the Pharmaceutical division. Establish clear performance expectations and provide regular feedback and development support. Foster a culture of regulatory excellence, collaboration, and continuous improvement. Champion Barentz' values, safety practices, and strategic goals across the team. Other Duties and Responsibilities*
Participate in relevant industry associations, such as Responsible Distribution & IPEC-Americas, etc. Chair the Management Quality Meeting (MQM) and contribute to corporate regulatory and quality meetings as well as special projects. Support and lead by example by embracing Barentz's culture, strategies, pillars, and fundamentals. Act legally and ethically in all professional relationships in adherence with Barentz' values and fundamentals. Perform other duties, as requested. Required Education, Experience, Knowledge, and Skills
Bachelor's degree in Chemistry, Pharmacy, Regulatory Affairs, or related field. Post-graduate certification in Regulatory Affairs, Quality Assurance, or similar is an asset. A minimum of five (5) years+ proven experience in a regulated distribution environment, ideally focused on excipients, APIs, or raw materials in the pharmaceutical or nutraceutical industry, preferably in excipient distribution. Strong knowledge of excipient regulatory requirements, GDP, GMP, ECXiPACT, international guidelines, and customer quality expectations. Experience managing customer, regulatory, and supplier audits and inspections, and documentation controls systems. Knowledge of customs classifications and import/export regulations is advantageous. Proficient in Microsoft Office and Adobe, experience with ERP and QMS systems preferred. Excellent communication, analytical, and organizational skills; able to manage complex tasks across multiple priorities. Proven ability to work collaboratively across different departments and geographic locations while ensuring compliance and staying focused on goals. Effective in building constructive relationships and encouraging collaboration. Self-motivated, high energy, and engaging level of enthusiasm and positive outlook. Act legally and ethically in all professional relationships in adherence with Barentz' values and fundamentals.
Essential Duties and Responsibilities*
Regulatory Compliance Leadership
Ensure that the division and product portfolio comply with all applicable regulatory agencies (e.g., FDA, Health Canada, EPA, DOT) and industry standards (e.g., EU GDP for excipients, IPC-PQG GMP, EXCiPACT, USP ). Interpret and communicate the evolving regulatory requirements for excipients and related materials, outlining their business impacts to internal stakeholders and customers. Manage and maintain regulatory documentation, including Safety Data Sheets (SDSs), regulatory and technical questionnaires, and various certificates such as TSE/BSE, GMO, allergen, residual solvents, elemental impurities, DMF references, and Kosher/Halal certifications, as well as REACH compliance and others. Prepare and manage documentation for customer audits and regulatory inquiries, including Quality Statements and Regulatory Summaries. Product and Supplier Qualification and Oversight
Conduct regulatory and quality evaluations for both new and existing products and suppliers to ensure compliance before their commercial introduction. This process includes reviewing chemical regulations, import/export codes, technical dossiers, risk assessments, aligning quality agreements, and assessing end-use regulatory requirements. Coordinate cross-functional review and approval of product documentation (e.g., CoAs, specifications, safety data sheets, GMP statements) to ensure compliance with industry standards and customer requirements. Assess the regulatory acceptability of materials for target markets such as pharmaceuticals, biopharmaceuticals, and nutraceuticals. This includes evaluating DMF references, ensuring compliance with relevant pharmacopeias (e.g., USP, Ph. Eur.), and identifying any pertinent import/export restrictions. Evaluate and oversee excipient manufacturers, distributors, and brokers through documentation reviews, risk assessments, and audits as necessary. Manage supplier qualification and ongoing monitoring processes, including the review of certifications such as EXCiPACT and ISO, as well as third-party audits. Maintain the Approved Supplier List and conduct ongoing risk assessments of excipients, considering supplier performance, material criticality, and intended use according to the IPEC risk evaluation framework. Quality Systems Management
Lead the implementation, maintenance, and continuous improvement of the QMS by incorporating principles from ISO 9001, EXCiPACT GMP/GDP, IPEC guidelines, and Responsible Distribution. Coordinate internal and external audits, ensuring audit readiness and documentation availability. Oversee document control processes, including critical records, such as SOPs, product specifications, CoAs, CoCs, and change notifications. Manage and track quality events, including deviations, complaints, and change controls, ensuring timely root cause analysis and CAPA implementation. Maintain and enhance Quality Agreements with suppliers and customers. Support recall and traceability efforts as needed. Champion continuous improvements by establishing risk-based quality controls in partnership with operations, supply chain, and commercial teams. Customer Regulatory Support & Product Compliance Guidance
Act as the primary regulatory/quality liaison for pharmaceutical, biopharmaceutical, and nutraceutical customers. Provide prompt support and responses for product inquiries, audits, compliance documentation, product traceability, certificates, regulatory declarations, and technical questionnaires. Collaborate with Operations, Sales, and Commercial Teams to ensure regulatory alignment during onboarding of products, suppliers, and customers. Proactively and clearly communicate important regulatory changes to internal stakeholders and customers. Training & Continuous Improvement
Design and deliver internal training on essential regulatory topics, including GDP, IPEC-PQG GMP, and document management. Provide continuous education to cross-functional teams on current regulatory requirements, quality standards, and compliance expectations to ensure alignment and awareness across the organization. Lead initiatives to support quality process improvement, reduce compliance risks, and enhance overall system efficiency. Monitor and report on key performance indicators (KPIs) related to quality and compliance, and engage in regular quality and risk management reviews to promote data-driven decision-making and improvement strategies. Team & Performance Management
Supervise and mentor Regulatory Specialist within the Pharmaceutical division. Establish clear performance expectations and provide regular feedback and development support. Foster a culture of regulatory excellence, collaboration, and continuous improvement. Champion Barentz' values, safety practices, and strategic goals across the team. Other Duties and Responsibilities*
Participate in relevant industry associations, such as Responsible Distribution & IPEC-Americas, etc. Chair the Management Quality Meeting (MQM) and contribute to corporate regulatory and quality meetings as well as special projects. Support and lead by example by embracing Barentz's culture, strategies, pillars, and fundamentals. Act legally and ethically in all professional relationships in adherence with Barentz' values and fundamentals. Perform other duties, as requested. Required Education, Experience, Knowledge, and Skills
Bachelor's degree in Chemistry, Pharmacy, Regulatory Affairs, or related field. Post-graduate certification in Regulatory Affairs, Quality Assurance, or similar is an asset. A minimum of five (5) years+ proven experience in a regulated distribution environment, ideally focused on excipients, APIs, or raw materials in the pharmaceutical or nutraceutical industry, preferably in excipient distribution. Strong knowledge of excipient regulatory requirements, GDP, GMP, ECXiPACT, international guidelines, and customer quality expectations. Experience managing customer, regulatory, and supplier audits and inspections, and documentation controls systems. Knowledge of customs classifications and import/export regulations is advantageous. Proficient in Microsoft Office and Adobe, experience with ERP and QMS systems preferred. Excellent communication, analytical, and organizational skills; able to manage complex tasks across multiple priorities. Proven ability to work collaboratively across different departments and geographic locations while ensuring compliance and staying focused on goals. Effective in building constructive relationships and encouraging collaboration. Self-motivated, high energy, and engaging level of enthusiasm and positive outlook. Act legally and ethically in all professional relationships in adherence with Barentz' values and fundamentals.