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.