Head Quality Assurance: Clinical Studies Phase I to IV

Head Quality Assurance: Clinical Studies Phase I to IV

Position open only to Canadian citizens or residents or with Canadian work permit.

Full Time

Seriant is a contract research organization based in Montreal with a global reach. We believe that great minds change the world. We’re looking for passionate individuals to join us in transforming lives, one study at a time. At Seriant, your work matters, your growth is encouraged, and your impact is real. Join us and be part of something bigger.

Responsibilities

• Ensure the administration and efficiency of the Quality Assurance department in order to achieve organizational objectives.
• Develop, implement and administer the quality management system in accordance to applicable international regulations/guidelines.
• Oversight of system validation activities.
• Define, together with the Executive Director, expectations with regards to quality assurance and clearly communicate them to the organization.
• Present all significant quality issues to management to ensure the continuing suitability, adequacy and effectiveness of the quality control system.
• Ensure mentoring and development of personnel.
• Evaluate the performance and progress of the QA personnel.
• Ensure that relevant information resulting from regulatory inspections, regulations etc. is appropriately shared among facilities and when appropriate, corrective actions are implemented throughout the organization.
• Host sponsor and regulatory agency audits.
• Perform GCP training.
• Play a consultative role to staff for quality assurance or regulatory compliance.
• Responsible for the archives and documentation.
• Schedule and perform audits for compliance with procedures and regulations.
• Perform follow-ups and archiving of QA documentation.
• Execute or participate in other QA activities or special projects.

Requirements

• Bachelor’s degree in life sciences or related discipline.
• Minimum of five (5) years of quality assurance experience in the pharmaceutical or biotechnology industry within a GCP environment and two (2) years of experience in managing teams.
• Strong leadership, project management and interpersonal skills.
• Must have strong analytical and problem-solving skills.
• Prioritize effectively.
• Must demonstrate excellent organization, communication and management skills and leadership skills.
• Bilinguism (French/English) - MANDATORY.
• Computer literacy and proficient in Microsoft Office including Excel and MS Office 365.
• Clinical database systems, software validation, computer literacy, FDA, ICH, EMA and Canadian regulations and guidelines.
• Knowledge of eQMS of Montrium, EDC InForm d’Oracle and eTMF FlexGlobal (an asset).

WORK CONDITIONS

• 35 hours weekly base.
• Pre-approved overtime paid.
• Flexible work schedule for work-family balance.
• Hybrid model (working from home and office).
• 6 weeks’ vacation after one year.
• 13 statutory holidays.
• Defined retirement benefits.
• Group insurance.
• 9.6 days off sick days.

Seriant offers a wide range of benefits aimed at the health, well-being, and quality of work life of employees, including free access to the EPIC Center, as well as various other benefits.

TO SUBMIT YOUR APPLICATION:

• Deadline to apply: May 30, 2025.
• Please attach your cover letter and resume.

Seriant subscribes to an equal access program. Applications from targeted groups (women, visible minorities, ethnic minorities, Indigenous peoples, and persons with disabilities) are encouraged.

We thank all those who apply to this position but only candidates that have been selected for an interview will be contacted.