Head of Quality and Regulatory Affairs

Location:  Ste-Julie, QC (Montreal)

Company

Established in 2009, Biomod Concepts is a young, innovative and dynamic company that combines science and textiles for the cosmetic and pharmaceutical fields. The company is growing rapidly and is currently looking for exceptional individuals to complete its team. A market-disrupter, established supplier to internationally recognized brands and holder of a worldwide intellectual properties portfolio, our leading edge products have tremendous potential for a very large array of applications,ready to market. We operate in a B2B environment that moves very quickly and requires agility and adaptability. Our team is multidisciplinary and our culture is based on innovation and teamwork. For more information on the company: www.biomod.com

Overview

The Head of Quality and Regulatory Affairs provides quality oversight throughout the product development and commercial lifecycle. The incumbent in this role is responsible for the maintenance and advisement of Quality Assurance and Regulatory Affairs as it relates to Quality Systems and associated ISO standards (ISO 22716, ISO 9001) and Good Manufacturing Practices.  The incumbent in this role will be a key contributor in the company’s drive to create superior enterprise value, growth alternatives and investment strategies. The Head of Quality and Regulatory Affairs will be expected to establish and lead a best-in-class team and build a platform which can potentially facilitate future investments and new product development. 

Key Responsibilities

  • Provide a proactive front-end approach to product quality by ensuring quality and compliance are ingrained and built into the process during product development and commercial supply
  • Establish and track product metrics, monitor overall product quality performance and the integrity and quality of the product supply chain
  • Lead continuous improvement initiatives to enhance performance and/or mitigate quality or compliance risks
  • Ensure that the quality of a product meets predefined quality and compliance requirements throughout the manufacturing process.
  • Revise and update quality procedures
  • Develop relevant training materials and train employees on quality procedures
  • Overall accountability for the release of raw materials, components and finished product
  • Supervise the preparation of requests for internal and external analyses
  • Support customers on quality aspects of products, including collaborating on the application of Good Manufacturing Practices according to specific specifications and ensure all issues are resolved, including but not limited to customer complaints and non-conformance.
  • Coordinate internal and external audits
  • Inform management of any quality deviations and implement corrective and preventive actions when necessary
  • Lead the creation of the Annual Product Review / Product Quality Review and other product-specific quality documents as required.
  • Support regulatory filings, inspections and compliance audits for assigned products.
  • Work closely with development teams to write, review, and revise documents for submission to regulatory health authorities to ensure appropriate planning, review, and tracking of all regulatory submission documents; acceptability of data, procedures, and other documentation presented in support of product trials
  • Identify requirements during the review of product registration files and obtain required approvals
  • Follow clinical studies on finished products with third party providers and partners
  • Support customers on regulatory aspects of their products
  • Lead the development and implementation of regulatory strategies and applications.
  • Provide advice and direction to product strategy teams, including identifying and assessing regulatory risks
  • Perform regulatory intelligence activities to keep current on the global regulatory environment and competitive products
  • Ensure all relevant information is communicated to the teams internally

Qualifications

To be considered for this role, you must have a university degree in Science (i.e. Chemistry, Biochemistry), Engineering or related discipline and a minimum of 7 – 10 years’ experience in a regulated manufacturing environment preferably in the cosmetic, health and/or beauty industries. Experience working in a start-up company environment would be considered a definite asset.

In addition, you have proven experience and/or demonstrated the following skill sets:

  • Experience in overseeing and managing Regulatory commitments and trackers/amendments
  • Good understanding and expertise in applicable Regulations and good manufacturing practices
  • Proven ability to translate strategy into action
  • Experience handling sensitive and/or confidential proprietary information
  • Highly organized with attention to detail
  • Excellent scientific writing, presentation and documentation skills
  • Familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications
  • Strong communicator
  • Excellent written/verbal skills in French and English

Interested candidates should submit their application via LinkedIn