Title: Regulatory Compliance Manager

Job Overview:

This position is primarily responsible for managing the quality, regulatory and environmental programs for Dextran Product's Scarborough, Ontario Facility. This position would be ideal for a quality professional who is seeking a challenging opportunity with a small manufacturing plant that is part of a growing Bio-Pharmaceutical Company.

Key Responsibilities:

• Management of Multiple Plant Functions:
  1. Management of the Quality, Regulatory and Environmental and Safety Programs at Dextran Products.
  2. Ensure accurate and complete documentation is provided in support of product commercialization.
  3. Author, review and approve quality assurance, compliance, lab, safety and environmental procedures.
• Manages Quality Assurance and Quality Control Personnel:
  1. Provide leadership to the plant with respect to quality systems, compliance, quality control, safety and environmental procedures and systems.
• Regulatory Program Management: Manage Dextran's regulatory program to ensure compliance with internal SOPs and external regulations.
• Corrective and Preventative Action: Conduct internal audits, investigate discrepancies and oversee corrective and preventative actions for all Regulatory programs.
• Review/Approve Qualifications & Validations: Author, review and approve qualifications and validations related to process equipment and laboratory instruments.
• Manage Change Control Process: Manage change control program including issuance, approval and communication to support implementation.
• Customer & Regulatory Audits: Host and prepare for customer and regulatory audits.
• Quality & Manufacturing Training: Implement and manage the quality and manufacturing technician training program to ensure compliance with procedures and regulations.
• Quality Control Department Management
  1. Oversees QC testing, reviews and implements testing procedures to ensure compliance with Dextran's QC testing procedures and in order to meet customer order requirements.
  2. Develops, reviews and approves lab testing method validations.
  3. Manages the effectiveness of lab testing equipment through preventative maintenance and ensures adequate inventory of laboratory supplies.
• Environmental, Health & Safety: Works with Corporate EHS to ensure Dextran's environmental, health and safety program is effective and meets federal and provincial legal requirements.
• Chemical Safety Program: Manages plant chemical safety program, including developing and implementing procedures, conducting safety training, PPE and chemical handling to ensure compliance with safety and environmental standards and regulations.

Skills & Qualifications:

• Education: Bachelor's degree in Science, Engineering or related field or the equivalent in related experience.
• Experience: A combination of seven or more years of experience in EHS, quality control, quality assurance and/or compliance within a GMP chemical manufacturing facility.
• Skills & Capabilities: The ideal candidate will have demonstrated the following abilities:

o Demonstrated working knowledge of quality control testing and be able to review and approve lab testing methods.

o Demonstrated working knowledge of regulatory requirements and be able to create, review and implement procedures and documentation that ensure Dextran's regulatory compliance.

o Capable of building an internal audit program that will ensure compliance with Dextran's regulatory, quality control, quality assurance, environmental and safety programs.

o Leadership to direct plant staff and work collaboratively with multiple stakeholders to drive a level of excellence across the Company's regulatory, quality control, environmental and safety programs.

o Effective communication skills and the ability to critically assess and take decisive action to achieve results.