Quality Assurance Manager (Traveling)

This role follows a hybrid work schedule, with 2 days per week in the office (Toronto) and 3 days per week working remotely or time spent at donor centers

This may vary depending on task assignments, inspections, or projects

Frequent travel to donor centers throughout Canada is a must

The Traveling Quality Manager is responsible for supporting all on-site quality systems and related processes to ensure that all quality standards of the company are followed and implemented as written and escalating any potential issues to the Regional Quality Manager where applicable.

• Provides quality support and/or quality staff coverage at centers in the designated Region; may also be required to provide support outside of the Region periodically.
• Maintains certification and performs all responsibilities of a Center Quality Systems Manager.
• Collaborate with Regional Quality Manager, Center Quality staff, and Center Operations leadership to ensure product quality, donor suitability, and donor safety by improving staff accuracy through activities such as enhanced training, clear communication of procedures, error reduction strategies, and fostering a culture of compliance and accountability
• Directs and monitors processes and ensures center compliance with all applicable regulations, company-designated procedures and policies, best practices, and quality principles.
• Ensures that Standard Operating Procedures (SOPs) are correctly interpreted, implemented on time, and that the staff executes procedures as intended.
• Assists with all aspects of internal and external audits, including scribing, review of and/or assisting with the preparation of audit responses, development of corrective and preventive action, implementation and assessment of corrective and preventative actions, and other follow-up as required
• Performs periodic quality assessments to ensure center compliance and quality excellence.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
• Works with center operations and quality staff to develop corrective and preventative actions; follows up to measure/determine effectiveness.
• Tracks/trends center quality incidents; reports critical incidents and problematic trends to the Regional Management.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

EDUCATION

Bachelor’s degree in one of allied sciences (chemistry, biology or medical technology) or related field or professional equivalent such as Registered Nursing /license or Medical Technologist license. Evaluation and/or translation of any foreign education (high school, college, or professional training) applicable to the position must be provided.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Knowledge – Skills – Abilities

Strong organizational and problem-solving skills, strict attention to detail. Excellent interpersonal, written, and verbal communication skills, proven critical and analytical thinking skills. Strong integrity and commitment to quality and compliance. Legible handwriting. Ability to balance multiple competing priorities. Strong time management abilities. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision. Working knowledge of GMPS, quality systems, quality control, and quality assurance concepts required. Must be self-motivated and possess the initiative to identify and address concerns proactively. Ability to read and write the English language at a professional level. Ability to articulate clearly and conduct oral presentations in English. French is not required. Must have legible handwriting. High level of proficiency with computers.

Additional Responsibilities

• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation, and review of center documents.
• Continuously looks for process improvement opportunities; collaborates with Regional Management to develop and execute approved project plans, leads projects and initiatives for the region.
• Develops and delivers training to the Region’s Quality staff to increase engagement, ensure continued development, and build knowledge of quality principles.
• Works in collaboration with the Regional Quality Manager and Center leadership to develop the center staff knowledge of their job function and how their performance relates to the product and patient.
• Works in collaboration with Regional Management to ensure training for the region is completed on time, and monitors to ensure the training is effective. When necessary, develops supplemental training to reinforce and ensure compliance within the Region.
• Timely completion of required administrative tasks (expense reports, timekeeping, travel authorizations, etc.). Other projects and assignments as assigned

OCCUPATIONAL DEMANDS

May be exposed to short periods of time in sub-freezing temperatures. Limited occupational exposure to blood-borne pathogens. Frequent standing, walking, sitting, bending, and twisting; may infrequently squat, crouch or sit on one's heels. May frequently lift 25 to 35 lbs, with a maximum lift of 50lbs. Color perception/discrimination, near vision, and far vision are correctable in one eye to 20/30 and to 20/100 in the other eye. Able to read, comprehend, and follow instructions in English to complete assigned tasks. Must possess the ability to listen to and understand information in English and ideas presented through spoken words and sentences. Must perform within the guidance of both oral or written instructions. Ability to travel via automobile, airplane and/or other ground transportation frequently. Weekends and holidays as needed.

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