Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

The candidate must be located or willing to relocate to the Greater Toronto Area, Ontario. Up to 100% travel.

Job Title: Regional Quality Manager

Summary:

The Quality Regional Manager is responsible for overseeing all on-site quality systems and related processes to ensure that all quality standards of the company are being followed and implemented as written. The Quality Regional Manager is also responsible for overseeing the direct work of the local Quality Systems Managers and escalating any potential issues to the Quality Director where applicable.

Primary responsibilities:

• Direct supervision of the donor center quality teams including hiring, training, performance management, professional development, discipline and termination. Ensure donor centers are adequately staffed and trained to carry out the required quality activities.

• Provide on-site support for day-to-day activities; conduct scheduled and unscheduled donor center inspections on a regular basis.

• Interact with center and corporate level quality and management teams to monitor compliance and implement corrective measures to ensure center activities are compliant and continue to produce desired results.

• Identify and propose preventive actions in response to emerging quality needs.

• Identify procedural deficiencies and process improvement opportunities; submit change/improvement requests.

• Assure compliance with all applicable regulations, industry standards, and company-approved Standard Operating Procedures.

• Ensure SOP revisions are implemented on time and that personnel have received adequate training; monitor post-implementation to ensure changes are carried out as directed.

• Host regulatory, customer, and internal audits; interact with the quality and management teams to develop corrective actions for audit observations and ensure they are implemented in a timely and effective way.

• Ensure quality event activities are handled appropriately and timely; assist in root-cause analysis and formulation of corrective and preventative actions; evaluate the adequacy and effectiveness of implemented CAPA.

• Ensure that required proficiency testing is performed, reviewed, and reported on time.

• Monitor and analyze customer complaints. Track and trend errors, deviations, and audit findings.

• Maintain frequent, timely, thorough, and effective communication with the Director of Quality regarding quality systems management and issues impacting the quality performance of assigned centers.

• Collaborate with Operations management to effectively guide and grow the donor centers.

• Collaborate with the Training department to ensure appropriate and adequate training of donor center staff; develop and deliver ongoing training for quality staff.

Additional responsibilities:

• Timely completion of required administrative tasks (expense reports, timekeeping, travel authorizations, etc.). Other projects and assignments as assigned by the Director of Quality.

• 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.

Requirements:

• 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.

• EXPERIENCE: Typically requires a minimum of 5 years of related work experience in a GMP regulated laboratory, biologics/drug manufacturing, medical device or in-vitro diagnostic environment. Project or technical leadership experience required. Supervisory or management experience preferred, experience managing remote staff helpful.

• EQUIVALENCY: 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 typically requires a Bachelor's degree plus plus 4 years of experience, an equivalency could include 8 years of experience, an Associate degree with 6 years of experience, or a Master's degree with 2 years of experience.

• KNOWLEDGE, SKILLS, & ABILITIES: Previous work experience should demonstrate good interpersonal, written and verbal communication skills, proven use of critical and analytical thinking skills. Working knowledge of Canadian Blood Regulations, good manufacturing practice guidelines and international regulations (knowledge of European, ISO and/or FDA regulations is an asset).Ability to perform tasks independently with minimal supervision and motivation/initiation to identify and address concerns proactively. Strong knowledge of cGMPs, pertinent federal and provincial regulations, SOP interpretation and implementation as well as a thorough understanding of quality systems, quality control and quality assurance concepts. Ability to articulate clearly and conduct oral presentations. Must have legible handwriting. Ability to read and write the English language at a professional level. French is not required. Proficient in the usage and handling of computers and related peripherals. Managerial experience is an asset.

Occupational Demands: May be exposed to short periods of time in freezing temperatures. Limited occupational exposure to blood borne pathogens. Ability to travel via automobile, airplane and/or other ground transportation frequently. Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments, gloves and cold gear. Work is performed sitting or standing for entire shift, bending and twisting neck and waist for 1-2 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement: may infrequently squat, crouch or sit on one's heels. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to comprehend and follow instructions to complete assigned tasks. Must possess the ability to listen to and understand information and ideas presented through spoken words and sentences. Must perform within the guidance of both oral and written instructions. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to their occurrence. Relates sensitive information to diverse groups.

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Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 517754

Type: Regular Full-Time

Job Category: Quality