Job Number: 874260

Category: Research

Positions Available: 1

Years Experience Required: 5

Location: Toronto, Ontario

Posted Date: Mar 30, 2021

EMPLOYMENT OPPORTUNITY

Manager, Quality Assurance

Research Services

 

The Centre for Addiction and Mental Health (CAMH) Research Services Office is seeking a Manager, Quality Assurance to bring leadership and expertise to the areas of Quality Management Systems, Risk Management, Education, Auditing, Monitoring of Clinical Research (regulated and non-regulated) and Regulatory Inspections.

 

Job Description:

Reporting to the Acting Director of Research Strategy, Policy and Operations, you will enhance CAMH’s capability and capacity for high quality research by identifying, supporting, expanding and implementing opportunities for compliance, risk management, and dissemination of best practices and current information in the field of research quality assurance. You will provide guidance to the CAMH Research Institute, QA team, team-based monitors, and researchers and their teams, to manage Quality Assurance activities across the CAMH research enterprise.

You will manage the ongoing development, implementation, administration and documentation of quality assurance and quality control policies, systems, and activities to ensure that CAMH human participant research is conducted, documented and reported in compliance with all applicable regulatory requirements and internal, domestic, and international standards for human participant research, including pharmaceutical drug, natural health product & medical device studies.

You will identify, evaluate and mitigate study and institutional risks through collaboration with Directors, Research Services team, department managers and staff to and support the development, implementation of robust corrective and preventative action plans for identified risks.

You will initiate and cultivate collaborative and cross-functional relationships with key stakeholders and departments to ensuring a system-wide approach to research quality assurance and facilitate collaboration with external partners.

You will manage the ongoing development and implementation of a comprehensive research quality assurance training plan and continuing education for stakeholders, to address legislation, internal control gaps, and taking into account the organization’s existing knowledge level.

You will support a workplace that embraces diversity, encourages teamwork and complies with all applicable regulatory and legislative requirements.  This position will be located at 33 Ursula Franklin Street, Toronto, however, you will temporarily work remotely due to the pandemic.

 

Key Accountabilities:

  • Lead risk management in the Research program; coordinate initiatives for identification of areas of exposure, develop and implement counter-measures to mitigate risks.
  • Provide expertise in corrective and preventative actions (CAPA) management; support and provide education and guidance in developing robust CAPA and monitors resolution; provide guidance for research related activities.
  • Use continuous improvement methodologies to refine and improve the current CAMH quality control and quality assurance program and oversee Quality Management System
  • Collaborate with the Quality Assurance team and develop and maintain internal and external quality networks.
  • Lead the Inspection Readiness Program across CAMH Research and response management; Health Canada, FDA, EMA and other agency inspections.
  • Lead QA program enhancement according to principles of process improvement, knowledge building and project management.  Expand QA program to include all Clinical Research; lead & support development of Research Education training program; lead management of the clinical trials registries used by CAMH Researchers to post clinical trials in the public domain.
  • Foster collaborative partnerships and lead capacity / capability building in the Research Program.

 

Qualifications:

The successful candidate will possess  a Bachelor’s Degree in Life Sciences. An advanced degree, post-graduate certificate in Clinical Research, and/or certification in Clinical Research (SOCRA/ACRP) is an asset. Experience working in a research environment in a hospital and academic environment is required. A minimum of five (5) years of related experience managing a quality assurance program or in a quality assurance auditor role in a hospital or pharmaceutical setting is required. Demonstrated experience in policy and standard operating procedure development and recognized process and quality improvement methods is required. Demonstrated understanding of, and experience with, applicable Canadian and international regulations, legislation, and regulatory agencies, combined with the ability to evaluate and apply that understanding to complex situations to effectively solve problems.  Previous supervisory experience required.  Experience in the formulation/implementation of internal communication strategies would be advantageous. Excellent interpersonal, communication (verbal and written), reporting and strong time management and organizational skills are required. Demonstrated ability to manage a system-wide program incorporating diverse stakeholders is required. Ability to provide leadership and facilitate change management through influence, innovative practices and teaching skills, to foster a culture of responsiveness, compliance awareness, self-regulation, quality system ownership, and continuous improvement, in order to achieve the highest level of compliance. You possess sound judgment, negotiation, conflict management, strategic planning, and advanced facilitation and teamwork skills.  Problem solving, networking and partnership building skills are also required. You possess excellent computer skills in the areas of quality assurance and advanced computer skills in a Microsoft office environment.  Candidates require the ability to work effectively with individuals from diverse backgrounds. Bilingualism (French/English) and/or proficiency in a second language would be an asset.

  

Please note:  This full-time, permanent position is NOT part of any bargaining unit.    

 

Salary range: Competitive salary and benefits package.

 

 

CAMH is a Tobacco-Free Organization.

CAMH is fully affiliated with the University of Toronto and is a teaching hospital and research institute.  As a CAMH employee, you will be expected to actively support CAMH’s teaching and research activities, in addition to supporting the clinical work of the hospital.

At CAMH, we strive to be an equitable and inclusive employer. Our commitment to equity is grounded in an institution-wide commitment to achieving a working, teaching, and learning environment that is free of discrimination and harassment.

CAMH actively seeks candidates from First Nations, Métis and Inuit, racialized and LGBTQ2+ communities, women, and people with disabilities (including people who have experienced mental health and substance use challenges).

We encourage people from all backgrounds to apply to our positions.

We thank all applicants for their interest, however, only those selected for an interview will be contacted. Please inform us if you require accommodations during the interview process.