Quality Assurance Manager - Clinic

Pharma Medica Research is a full service Contract Research Organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are always looking for top talent to join our amazing team! Currently we are looking for a Quality Assurance Manager for our Clinical QA department.

The Manager, QA (Clinic) is to be responsible for managing the operation of the Clinical QA Department of Pharma Medica Research Inc (PMRI) which includes Quality Assurance. This position reports to the Director, QA and/or designate.

Duties and Responsibilities

• Perform Vendor Qualifications to ensure compliance with applicable regulatory requirements.
• Ensure that QA audits are effectively scheduled and conducted as per regulatory and PMRI requirements, monitor implementation and effectiveness of corrective actions.
• Perform HR related activities.
• Manage the Clinical QA departmental which includes Quality Assurance day-to-day activities.
• Follow PMRI Health and Safety policies.
• Review departmental Standard Operating Procedures (SOPs) for compliance with applicable regulatory requirements; write and revise quality assurance and corporate SOPs.
• Report to Senior QA Management, the status of audit findings, monitoring activities and regulatory compliance, on a regular and timely basis.
• Other duties as required
• As required, participate in regulatory and sponsor audits; monitor corrective actions.
• Interact with departmental management and staff to maintain a positive attitude towards regulatory compliance.
• Responsible for the training of Clinical QA personnel; develop and maintain PMRI corporate, quality system and GCP training programs.

All managers and supervisors shall work according to the applicable provisions set out in the Occupational Health & Safety Act (sections 25, 26, 27 & 28), in addition to all health & safety policies and procedures as set out by PMRI.

Qualifications

• B.Sc. degree in a scientific, healthcare, or pharmaceutical field or equivalent
• Sound decision making ability based upon regulatory experience and knowledge
• 3+ years experience in quality assurance supervisory/management role
• Proven knowledge of related regulatory requirements (GCP)
• Excellent communication and interpersonal skills

Why is PMRI the place for you? We offer:

• Competitive compensation plan
• Learning Support Programs
• Mentorship Opportunities
• Opportunities for advancement and career progression
• A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution Plan
• Corporate Discounts Program
• A generous Employee Milestones Awards Program
• Friendly atmosphere, culture of learning

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.