1. JOB OBJECTIVES

• The Head of Quality - CMO and Suppliers is responsible for quality assurance, quality control and compliance activities in support of the import and distribution of Juno Pharma Canada drug products and medical devices.
• The Head of Quality - CMO and Suppliers is responsible for operational activities relating to establishment licensing, batch review and lot disposition, vendor surveillance/oversight and audits, complaints, CAPAs and compliance, including SOPs, Validation/Qualification documentation and Change Control, and post-market vigilance activities.
• The Head Quality - CMO and Suppliers acts as an active influence toward elevating the quality practices and guidelines for products, imported, tested and distributed by Juno Pharma Canada.
• The Head Quality - CMO and Suppliers Quality Manager will already have established expertise relating to Health Canada guidelines for specialty hospital products.

2. PRIMARY FUNCTIONS

• Ensure that all operations are performed as per company guidelines, policies, SOPs and according to GMPs and Regulatory guidelines.
• Manage the vendor qualification program including audits.
• Ensure Quality Agreements with CMO's and suppliers are available and current.
• Maintain regulatory licenses, permits and approvals, Drug and Medical Device Establishment
• Release of pharmaceutical and biological products and medical devices imported from CMO maintaining Canadian Batch Release procedures to ensure compliance to Health Canada regulations.
• Liaise with cross-functional groups internally/externally to collect documents, information and support product launch activities as necessary.
• Manage quality systems records, document and label controls.
• Manage the APQR
• Manage complaints and the post-market vigilance program.
• Co-ordinate recalls in the marketplace, if required.
• Oversee the pharmaceutical manufacturing deviation/non-conformance investigations & CAPA
• Licenses, annual DN renewals.
• Write and enforce SOPs.
• Liaise with contract facilities and warehouse on quality issues.
• Lead/host regulatory inspections and audits.
• In depth knowledge of Canadian regulations, processes and issues for hospital generic drugs and biologics development and registration including detail knowledge of ICH, Health Canada guidelines, GMPs and offer relevant guidelines focus in area of specialization.
• Perform additional duties as assigned by VP Quality.

3. REQUIREMENTS AND SKILLS

• University Degree, B.Sc. or higher in Chemistry or Health Sciences.
• Post-Graduate Certification preferred.
• Minimum 7-10 years relevant Canadian experience in pharmaceutical Quality role.
• Sound knowledge and application of Canadian regulations.
• Detail oriented, superior problem-solving ability to identify solutions, planning, analytical and organizational skills to manage multiple concurrent projects within established timelines.
• Excellent communication (oral and written) and influencing skills; able to interact effectively and confidently both internally and externally.
• Proactive with high degree of self-discipline, drive and able to work with minimum supervision.
• Strong interpersonal skills with ability to work effectively and efficiently within a small team.
• Strong computer skills include Microsoft Office Suite and Adobe Acrobat.