Jennifer Roach Email & Phone Number

Burlington, On, Ca

Ontario, Canada

Accountable for developing and maintaining innovative, harmonized, compliant and sustainable quality systems, business management processes and global operational process governance for Global APQR & Complaint Operations. Ensures global process compliance to GMP regulations and compliant delivery of complaint investigations, leveraging matrix leadership and peer-coaching. This role also drives continuous process improvement.

Canada

Senior Global Complaint Manager responsible for handling product complaints (medical device, combination products, biological drugs and small molecule drugs) and conducting thorough investigations. Led cross-functional teams, collaborated with stakeholders, and applied advanced technical knowledge to address complex problems related to complaint investigations and complaint handling processes. Skilled in root cause analysis, developed solutions, and implemented process improvements… Show more Senior Global Complaint Manager responsible for handling product complaints (medical device, combination products, biological drugs and small molecule drugs) and conducting thorough investigations. Led cross-functional teams, collaborated with stakeholders, and applied advanced technical knowledge to address complex problems related to complaint investigations and complaint handling processes. Skilled in root cause analysis, developed solutions, and implemented process improvements. Demonstrated excellent communication and leadership skills, ensuring compliance with regulatory requirements and driving continuous improvement. Dedicated to delivering high-quality results and fostering effective partnerships. Show less

Oversees and manages the coordination and maintenance of the product complaint system in accordance with local, Global and Regulatory requirements. A member of the Investigations and Supplier Management team at Bayer Inc. Performs quality investigations and problem solving in accordance to Good Manufacturing Practices (GMPs), quality systems, manufacturing controls and corporate regulations.

Responsible for the investigation, documentation, closing and follow-up of quality (GMP and ISO) related investigations (including product complaints), ensuring compliance with local, corporate and regulatory requirements.

Toronto, Ontario

Responsible for managing compliance and risk management projects and activities related to the manufacturing of solid dose products.

Toronto Ontario

Responsible for compilation of quality regulatory submissions to ensure timely approvals for: Provincial formularies, Canadian, U.S. and International markets (eCTD and traditional formats)

Mississauga, On

Managed all compliance related projects and Quality System activities related to launching and continued marketing of the company’s over-the-counter (OTC) drug product lines.

Toronto, Canada Area

Investigated product quality and Adverse Drug Reaction complaints: review batch records and product history, request special testing and assess results, examine complaint and reserve samples

Bachelor Of Science (B.Sc.), Environmental Science And Biology

Environmental Engineering Technology Diploma, Environmental Engineering Technology/Environmental Technology