Position: Quality & Compliance Associate Reports To: Manager, Quality

The Quality & Compliance Associate jointly with the Manager, Quality is responsible for the quality assurance, quality control and compliance activities in support of the importation and distribution of JPC's drug products and medical devices.

The Quality & Compliance Associate will assist in the operational oversight and perform activities relating to establishment licensing, document control, batch record review, product dispositions, vendor qualification, self-inspections, complaints, pharmacovigilance, deviations, CAPAs, SOP writing, change control, process validation, analytical method validation/transfer and the fulfilment of post market commitments.

The Quality & Compliance Associate acts as a positive influence toward quality awareness throughout the organization. The position requires detailed knowledge of Health Canada regulations relating to drugs and medical devices. The successful candidate is detail oriented and is able to demonstrate problem solving skills to identify solutions. The role requires analytical thinking and exceptional time management abilities to progress multiple concurrent projects within established timelines.

KEY RESPONSIBILITIES AND PRIMARY DUTIES

• Ensure that all operations are performed as per company guidelines, policies, SOPs, GMPs and applicable technical guidance documents.
  
• Organize and schedule analytical testing for JPC's incoming finished goods.
  
• Release drug products and medical devices to the Canadian market according to current product disposition procedures ensuring compliance to Health Canada regulations.
  
• Liaise with internal and external teams to identify, request and obtain applicable quality system documentation as required by current records retention procedures.
  
• Support the creation and maintenance of quality system records, document filing and archival.
  
• Compile Annual Product Quality Review and Yearly Biologic Product Reviews or JPC's drug products.
  
• Support maintenance of JPC's global pharmacovigilance program including but not limited to documenting complaints/adverse events, notification to stakeholders and responses to customers/complainants.
  
• Support the vendor qualification program by performing self-inspections of the JPC quality management system, assist with onsite or virtual audits of JPC's GMP service providers and records maintenance related to vendor qualification status.
  
• Support the quality oversight of pharmaceutical manufacturing, packaging/labeling and testing deviations/non-conformance investigations and CAPA implementation at CMO's.
  
• Support maintenance of JPC's establishment licenses and GMP evidence of foreign buildings.
  
• Create/write, revise, review and enforce Juno's SOPs as needed to support operational activities.
  
• Support creation of training materials and provide SOP/GMP training as needed.
  
• Perform quality assurance impact assessment for internal and third-party related change control records.
  
• Review JPC's product labeling and promotional material for regulatory compliance.
  
• Initiate identified investigation reports, support the quality impact assessment, development and implementation of CAPAs with internal and external teams as needed.
  
• Support in any regulatory or third party audit of JPC as required.
  
• Review and evaluate product returns for disposition and destruction requests
  
• Perform additional duties as assigned by the Manager, Quality.
  

QUALIFICATIONS / EDUCATIONAL REQUIREMENTS / SKILLS

• University degree (B.Sc. or higher) in Chemistry, Biology, Biochemistry or Health Sciences.
  
• Post-Graduate Certification in Regulatory Affairs and Quality Assurance preferred.
  
• Detailed knowledge of Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, ICH guidance documents, GMPs and other relevant guideline with focus in sterile injectable.
  
• Minimum 0-3 years relevant Canadian experience in a pharmaceutical quality assurance or compliance role.
  
• Proactive with a high degree of self-discipline, drive and ability to work remotely or on-site with minimum supervision.
  
• Excellent communication skills to effectively interact with internal and external cross functional teams.
  
• Excellent in Microsoft Office Suite and Adobe Acrobat.