Clinical Quality Assurance Manager - CRO

Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people’s lives. Come join our team!

We are currently looking for a Quality Assurance Manager to join our clinical site in Scarborough!

The Manager, QA (Clinic) is 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 VP, Quality Assurance & Chief Privacy Officer and/or designate.

Duties and Responsibilities:

• Manage the Clinical QA department which includes Quality Assurance day-to-day activities.
• Ensure that QA audits are effectively scheduled and reviewed. Ensure that audits are conducted as per regulatory and PMRI requirements.
• Monitor implementation and effectiveness of corrective actions: identify areas of continuous quality improvement in QA and across departments.
• Interact with departmental management and staff to maintain a positive attitude towards regulatory compliance.
• Review departmental Standard Operating Procedures (SOPs) for compliance with applicable regulatory requirements; write and revise quality assurance and corporate SOPs.
• Responsible for the training of Clinical QA personnel; develop and maintain PMRI corporate, quality system and GCP training programs.
• Perform Vendor Qualifications to ensure compliance with applicable regulatory requirements.
• Report to Senior QA Management, the status of audit findings, monitoring activities and regulatory compliance, on a regular and timely basis.
• Conduct CAPAs; review departmental Investigation Reports (i.e. Clinical).
• Maintain current knowledge of regulatory requirements to ensure that PMRI’s QA department and compliance programs fulfill changing regulatory and industry needs.
• Provide effective regulatory direction to the QA department as well as PMRI management and staff.
• As required, participate in regulatory and sponsor audits; monitor corrective actions.
• Follow PMRI Health and Safety policies.
• Other duties as required.

Requirements:

• B.Sc. degree in a scientific, healthcare, or pharmaceutical field or equivalent.
• 3+ years of experience in a quality assurance supervisory/management role.
• Strong proficiency in computer usage and software applications.
• Excellent communication and interpersonal skills.
• Excellent organization and time management skills.
• Works closely with all departments and personnel to ensure PMRI’s quality objectives are achieved.
• Sound decision making ability based upon regulatory experience and knowledge.
• Proven knowledge of related regulatory requirements (FDA, EU, ICH GCP).

We offer:

• Competitive compensation plan
• 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
• Opportunities for advancement and career progression
• A generous Employee Milestones Awards Program
• Corporate Discounts Program
• Learning Support Programs
• 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.

We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.