COMPLIANCE SUPERVISOR

JUNO PHARMA CANADA INC.; Montreal; On-site; CAD 80,000 - 100,000; Full time

Job summary

A pharmaceutical company in Montreal is seeking a Compliance Manager to oversee and improve compliance systems. The role involves leading a team, managing CAPAs, and ensuring readiness for audits. The ideal candidate has a Bachelor's degree in engineering or science, 7-10 years of experience, and is bilingual in French and English. Strong organizational and analytical skills are essential.

Qualifications

• 7-10 years of experience in the pharmaceutical industry or equivalent.
• Ability to lead and manage cross-functional teams.
• Good judgment, autonomy, and initiative.

Responsibilities

• Implement and maintain compliance systems at Juno.
• Lead the Change Control Committee and manage CAPAs.
• Prepare for regulatory authority inspections.

Skills

Knowledge of Good Manufacturing Practices

Bilingualism (French and English)

Strong organizational skills

Analytical and problem-solving skills

Education

Bachelor’s degree in engineering or science

Tools

Microsoft Office

Job description

1. JOB OBJECTIVES

• Responsible for implementing, maintaining, and continuously improving the change control system, CAPA, complaints, internal audit, APQR, and document control processes at Juno.
• Manage and develop a team of 3-5 compliance associates.
• Support the head of compliance in day-to-day compliance activities.

2. PRIMARY FUNCTIONS

Lead the Change Control Committee to ensure that all relevant information is available to multidisciplinary teams to ensure the effective and compliant assessment of change requests.

Ensure the follow-up and closure of CAPAs issued according to established deadlines by rigorously monitoring the progress of deliverables and assigning follow-ups to ensure effectiveness.

Supervise and mentor compliance associates in their assigned activities

Approve CAPAs, complaints, and other quality documents related to their duties.

Help ensure that the site is always ready for audit.

Plan and conduct internal audits covering the various sections of GMPs.

Actively participate in preparing for regulatory authority inspections (SME training, setting up rooms, preparing lists, documentation, reviewing current topics, etc.).

Prepare and manage customer audits and draft final responses.

Promote the harmonization and improvement of quality systems within Juno.

Support other departments in improving compliance policies, procedures, and processes.

Ensure that deadlines are met and notify your supervisor and senior management of any changes made.

Act as a backup for key compliance positions.

Perform managerial duties for a compliance team of 3-5 people..

Perform any other related tasks deemed relevant to the position.

3. REQUIREMENTS AND SKILLS

Bachelor’s degree in engineering or science.

7–10 years of experience in the pharmaceutical industry or equivalent.

Knowledge of Good Manufacturing Practices

Bilingualism (French and English) and excellent written and oral communication skills.

Ability to communicate easily and work as part of a team with diverse clients.

Ability to lead, supervise, and manage or be part of various cross-functional teams.

Good interpersonal skills and ability to work with peers.

Good judgment, autonomy, and initiative..

Strong organizational skills.

Ability to negotiate and influence.

Knowledge of continuous improvement tools.

Analytical and problem-solving skills.

Knowledge of sterile pharmaceutical manufacturing structures and processes (an asset).

Proficiency in computer tools, particularly Microsoft Office.

Ability to work under pressure with tight deadlines / frequent changes in priorities.