Associate Director, Quality Assurance

June 6 2019
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Quality - Test - Inspection, Quality assurance and control - Validation
Montreal, QC

In close collaboration with the Senior Director, the Associate Director ensures mainly the execution of the audit program and the management of the activities related to the clients and regulatory inspections. Performs other supporting activities at the level of SOPs, investigations, training and regulatory compliance.

Responsabilities

More specifically, the Associate Director:
 

  • Support the Senior Director in the day-to-day management of the department's activities in order to achieve the annual objectives and various deliverables;
  • Acts as responsible person for the preparation and coordination of client audits and regulatory inspections. Also coordinates the completion of request of information (RFI);
  • Plans and performs audits according to the annual audit program. Take a systems-oriented approach to assessing quality.
  • Monitors corrective and preventive actions and ensures that they are implemented in a timely manner;
  • In collaboration with CRO operations, participates in vendor management activities (RFI, qualification and routine audits) and contributes to the development of a program focused on risk management;
  • Actively contributes to investigations and determination of action plan (CAPA). Can act as lead person;
  • Produces quality indicators and performs trend analyzes on a quarterly basis;
  • Acts as a trainer for new employees.

Other activities in which the Associate Director could also participate:

  • Writing and review of SOPs / Implementation of processes (QA department and CRO)
  • Consultation activities / regulatory compliance
  • Review of computer validation activities
  • Development of training such as Good Clinical Practice

Profil

  • Bachelor's degree in a relevant discipline or equivalent experience;
  • 5 to 10 years of experience in the quality sector (pharmaceutical or clinical research);
  • Excellent knowledge of ICH standards, Health Canada and FDA regulations;
  • Master the overall audit process including a systems-oriented approach;
  • Regulatory Inspection Management Experience (Preparation, Coordination, Responses);
  • Master the process of investigation, root cause identification and CAPA;
  • Strong ability to write audit reports and identify critical and critical issues;
  • Communicates effectively both orally and in writing;
  • Ability to adapt to a rapidly growing environment;
  • Bilingual: French and English, written and spoken;
  • Good knowledge of the Microsoft Office suite (Word, Excel, PowerPoint);
  • Willing to travel 10 to 30% of the time

 
Asset for the position:

  • Experience in Clinical Quality Assurance and Audit of Clinical Sites (Phases I-III)
  • Knowledge of the field of dermatology
  • Knowledge of European regulations
  • Experience in validation of computer systems

 

We thank you for your application and please note that only those selected for an interview will be contacted.

Innovaderm only accepts applicants with a work permit for Canada.

Apply now!

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