North America Quality & Regulatory Manager

The North America Quality & Regulatory Manager functions as the technical expert for regulatory and quality matters for the Pharmaceutical Division (which encompasses Pharmaceuticals, Nutraceuticals, Biopharma, OTC, and subsequent CMOs, CDMOs, CROs along with other distributors selling into these markets). This individual will lead initiatives to develop processes, procedures, and systems to meet regulatory and quality requirements while striving to enhance efficiency across departments. Further, the individual will direct investigations related to product quality and supplier compliance and make decisions based on quality indicators. The Quality & Regulatory Manager will interpret regulations to develop strategies in order to obtain regulatory approval of new opportunities and to maintain compliance of existing product lines. This individual must stay up-to-date on the regulations affecting the business and communicate the resulting changes as appropriate. The Quality & Regulatory Manager will oversee regulatory and quality requests from internal and external stakeholders and manage all regulatory and quality information.

Essential Duties and responsibilities*

Corporate Compliance:

• Regularly evaluating systems to ensure they are operating as intended. This involves providing feedback to senior managers regarding potential control issues and offering suggestions for improvement.
• Supporting division by implementing quality programs to better evaluate product suppliers for compliance and to manage risk.
• Educating employees on regulatory issues and requirements to improve general regulatory and product knowledge and mitigate risk in transactions.
• Implementing procedural improvements as part of the regulatory program to ensure regulatory requirements and industry standards are followed.
• Leading the Document Control system to improve the management of product and company documents as well as customer and supplier questionnaires. This involves facilitating the completion of questionnaires for pharmaceutics, while supporting other technical requests. Also includes authoring and issuing of compliant labels and safety data sheets (SDSs) according to regulatory requirements and ensuring document controls are performing as intended.
• Providing training in support of the QMS and RD
• Managing company certifications and licenses (under the oversight of the FDA, CFIA, etc.)
• Generating improvements to the company’s Quality Management System (ISO9001 certification) and Responsible Distribution™.
• Leading internal, customer, third party and government regulatory audits and inspections of principals, warehousing, distribution, and logistics companies, as needed. As well as managing all appropriate audit documentation for suppliers and liaising with suppliers to aid in audit requests.
• Working with Operations to develop controls for managing risk related to suppliers, customers, and internal operating activities.
• Conducting in-depth research to assure the understanding of regulations that impact existing and new products as well as associated business processes.
• Interpreting and using regulatory and quality guidelines to benefit the company through various stages of the supply chain.

Product and Supplier Compliance:

• Investigating quality issues to identify and correct root causes and make decisions based on quality indicators. As well as, leading in the development, implementation, and completion of corrective and preventative actions
• Organize regulatory information for easy reference and evaluation
• Making improvements to the product review system to make regulatory checks and evaluations more efficient and accurate.
• Ensuring a proper evaluation of products is conducted for compliance with workplace, transportation, and end-user specific application legislation for North America (i.e.,U.S. Environmental Protection Agency / U.S. Department of Transportation, Canadian Environmental Protection Act, Canadian Hazardous Products Act, Canadian Transportation of Dangerous Goods Act, The Federal Food, Drug, and Cosmetics Act, the U.S. Food & Drug Administration, Canadian Food and Drugs Act, regulations, and certifications, among other international regulations, as needed.
• Evaluating new opportunities and developing regulatory strategies to achieve compliance. This involves retrieving and submitting information to regulatory agencies or outside contractors to facilitate approvals and arranging consultation with regulatory agencies as appropriate.
• Evaluating and approving suppliers and supplier products to meet industry regulatory and quality requirements and maintain suppliers’ list for the Pharmaceutical Division
• Assisting in the management of Principal relationships by supporting Pharmaceutical Customers regarding questionnaires and technical inquiries and managing Customer and Supplier Quality Agreements, as necessary.
• Support RQM and business divisions on special projects, as requested
• Developing effective processes to assess ongoing supplier compliance with Barentz and industry expectations.
• Working with government agencies, contractors, external/internal customers in resolving any specifications/labelling discrepancies or incidents of non-compliance.
• Working with sales and marketing teams to ensure API listings and/or recommendations and product claims align with regulatory requirements and guidance documents.

Non Conformances:

• Review non-conformance trends to identify potential quality issues with suppliers. Follow up with appropriate departments to implement corrective actions.
• Provide regulatory and quality expertise and facilitate efficiency when implementing recalls or product traceability, as it pertains to division/customer needs.
• Ensure that non-conformances are addressed in a timely manner.
• Investigate and facilitate the resolution of quality-related non-conformances and determine corrective actions. Follow up with internal departments and external suppliers as needed.
• Escalate quality-related non-conformances as needed according to the NCR procedure

Other Duties and responsibilities*

Industry Association Participation (Responsible Distribution & IPEC Americas, etc.)

• Chair Management Quality Meeting (MQM) and special events.
• Perform other duties, as requested
• Attend corporate Quality Meetings (as necessary), including Pharma GDP Meeting and/or other US / Regional QRD meetings.
• Participate in ongoing professional development opportunities
• Act legally and ethically in all professional relationships in adherence with Barentz’ values and fundamentals
• Support and lead by example, Barentz’ culture, strategies, pillars, and fundamentals

Outside training and skills development relating to regulatory, project management, and quality assurance.

Required Education, Experience, Knowledge and Skills

· Bachelor of Science in chemistry or related discipline. Master of Science preferred.

· Post-graduate certification in regulatory affairs and quality operations an asset.

· At least ten (10) years+ proven experience in the Quality / Regulatory affairs related to the chemical distribution in pharmaceuticals.

· Attention to detail and organization, with a high standard of accuracy.

· Strong work ethic and ability to manage a heavy workload.

· Integrity, professionalism, and drive.

· Excellent technical report writing skills and the ability to understand and analyze technical documents, industry standards, processes, and procedures.

· High level of common sense and business acumen in order to provide successful solutions and recommendations.

· Adapts to change and shifting priorities easily.

· Effective in building constructive relationships, encourages collaboration.

· Strong verbal and written communication skills, coupled with an ability to share regulatory knowledge with confidence. Uses appropriate interpersonal styles and methods of communication to gain agreement or acceptance of a plan or activity.

· Computer skills using Microsoft Office (Outlook, Word, Excel, PowerPoint, as well as Adobe Writer).

· 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