Regulatory Compliance Manager

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:
• Management of the Quality, Regulatory and Environmental and Safety Programs at Dextran Products.
• Ensure accurate and complete documentation is provided in support of product commercialization.
• Author, review and approve quality assurance, compliance, lab, safety and environmental procedures.
• Manages Quality Assurance and Quality Control Personnel:
• 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
• 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.
• Develops, reviews and approves lab testing method validations.
• 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.