Medical Director - Canada Plasma Operations

Position title: Medical Director, Canada Plasma Operations

Reports to: Chief Quality Officer

The Medical Director, Canada Plasma Operations, provides strategic medical leadership and oversight for Grifols’ plasma collection operations across Canada. The role is accountable for ensuring donor safety, donor eligibility determinations, medical compliance, and the implementation of evidence-based medical practices across all plasma donor centers.

The Medical Director serves as the designated medical authority for plasma collection activities, providing guidance to center physicians, medical staff, operations, quality, regulatory affairs, and senior leadership. The position is responsible for ensuring compliance with applicable Canadian federal and provincial requirements, including the Food and Drugs Act, Food and Drug Regulations, Health Canada Blood Regulations, applicable provincial health legislation, standards from Canadian Blood Services (CBS) where relevant, and international standards including EMA, PPTA IQPP, and corporate requirements.

The Medical Director acts as the primary medical liaison with Health Canada and provincial public health authorities on matters related to donor safety, adverse events, donor eligibility, and medical oversight of plasma collection operations.

This role serves as the senior medical authority for Grifols Canada’s plasma collection operations and is responsible for fostering a culture of donor safety, scientific excellence, regulatory compliance, and continuous improvement.

Primary Responsibilities

• Medical Oversight and Donor Safety

• Provide medical leadership and oversight for all Canadian plasma donor centers.
• Ensure donor safety remains the highest priority in all plasma collection activities.
• Establish, maintain, and continuously improve medical policies, directives, and procedures related to:
  • Donor eligibility and suitability.
  • Donor assessment and selection.
  • Donor informed consent.
  • Donor counseling and education.
  • Management of donor adverse events and reactions.
  • Donor re-entry and deferral programs.
• Review and approve medical criteria used for donor acceptance, temporary deferral, permanent deferral, and donor requalification.
• Provide medical consultation and support for complex donor eligibility determinations.
• Serve as escalation point for significant donor medical events, safety concerns, and emerging donor risks.
• Oversee medical investigations

• Regulatory Compliance

• Ensure medical practices comply with:
  • Health Canada Blood Regulations.
  • Food and Drugs Act and Regulations.
  • Applicable provincial healthcare and privacy legislation.
  • Personal Information Protection and Electronic Documents Act (PIPEDA).
  • Provincial privacy requirements where applicable.
  • PPTA International Quality Plasma Program (IQPP) standards.
  • European Medicines Agency (EMA) requirements applicable to source plasma intended for fractionation.
  • Other applicable international regulatory requirements.
• Act as medical representative during Health Canada inspections, regulatory meetings, and compliance activities.
• Support responses to regulatory observations, corrective actions, and commitments involving medical operations.
• Monitor evolving regulatory and scientific developments affecting donor eligibility, donor safety, infectious disease risks, and plasma collection practices.

• Medical Leadership and Governance

• Lead the development, implementation, review, and continuous improvement of medical governance programs.
• Chair or participate in Medical Review Committees, Donor Safety Committees, Plasmavigilance Committees, and other governance forums.
• Establish medical performance indicators and monitor trends related to donor safety, donor reactions, donor retention, and operational medical performance.
• Review internal audits, inspections, quality metrics, and medical performance data to identify opportunities for improvement.
• Provide medical leadership for risk assessments related to donor safety and plasma collection operations.

• Physician and Medical Staff Management

• Develop and maintain standards for recruitment, qualification, training, credentialing, and ongoing competency assessment of:
  • Center Medical Directors.
  • Contract physicians.
  • Physician substitutes.
  • Medical support personnel.
• Oversee physician coverage strategies across the Canadian donor center network.
• Participate in physician recruitment, interviewing, onboarding, performance management, and contract review.
• Conduct periodic meetings and performance reviews with medical personnel.
• Ensure consistent application of donor eligibility criteria across all Canadian centers.

• Training and Medical Education

• Collaborate with Quality, Operations, and Training departments to develop and maintain training programs related to:
  • Donor assessment.
  • Medical screening.
  • Donor safety.
  • Adverse event recognition and management.
  • Emerging medical and epidemiological risks.
• Provide medical subject matter expertise for development and revision of Standard Operating Procedures.
• Support certification and recertification programs for medical staff.
• Promote evidence-based medical decision-making throughout the organization.

• Medical Surveillance and Risk Management

• Oversee donor safety surveillance programs and medical trend analysis.
• Review adverse event reports, donor complaints, and donor safety indicators.
• Lead medical assessments related to:
  • Emerging infectious diseases.
  • Epidemiological threats.
  • Public health alerts.
  • New donor screening requirements.
• Provide medical recommendations during public health emergencies or disease outbreaks.
• Collaborate with Quality, Regulatory Affairs, and Operations to implement risk mitigation strategies.

• Strategic Leadership

• Provide strategic medical input to senior leadership regarding plasma collection operations.
• Participate in business planning, regulatory strategy, expansion activities, and licensing initiatives.
• Support acquisitions, integrations, and new center openings from a medical oversight perspective.
• Contribute to development of long-term donor safety and medical governance strategies.
• Represent Grifols at industry organizations, professional societies, scientific meetings, and regulatory forums.

• Research and Scientific Affairs

• Monitor scientific literature relevant to plasmapheresis, donor safety, and transfusion medicine.
• Support development and execution of clinical and observational research initiatives when applicable.
• Collaborate with external experts, academic institutions, and industry groups.
• Contribute to scientific publications, presentations, and regulatory submissions as appropriate.

Education:

• Doctor of Medicine (MD) degree from an accredited medical school.
• Active unrestricted license to practice medicine in Canada, or eligibility to obtain licensure in any Canadian province.
• Certification by the Royal College of Physicians and Surgeons of Canada, College of Family Physicians of Canada, or equivalent recognized medical specialty certification preferred.

Experience:

• Minimum 10 years of progressive medical leadership experience.
• Minimum 5 years of experience in blood, plasma, transfusion medicine, hematology, donor medicine, public health, pharmaceutical, biologics, or regulated healthcare environments.
• Experience interacting with Health Canada and healthcare regulators preferred.
• Experience supporting inspections, audits, and regulatory submissions preferred.
• Experience leading geographically dispersed medical teams preferred.

Knowledge | Skills | Abilities

• Health Canada Blood Regulations.
• Food and Drugs Act and Food and Drug Regulations.
• Canadian blood establishment licensing requirements.
• Donor eligibility and donor safety practices.
• Transfusion medicine and plasmapheresis operations.
• Epidemiology and infectious disease risk management.
• Privacy legislation including PIPEDA and provincial privacy requirements.
• PPTA IQPP standards.
• EMA requirements for plasma used in fractionation.
• Strong leadership and change management capabilities.
• Excellent communication and stakeholder management skills.
• Strategic thinking and problem-solving ability.
• Ability to interact effectively with regulators, healthcare professionals, public health authorities, and senior executives.
• Strong analytical and risk assessment skills.
• Ability to travel domestically and internationally as required.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

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