Quality Assurance Auditor Jobs

About the Role

The Quality Assurance Auditor reporting to the Manager, Scientific Affairs, will be the expert in planning, leading, conducting, and reporting audit activities for GxP risk-based audit programs and fostering an industry-leading compliance culture within the organization. This role will partner with the internal and external cross-functional stakeholders and act as a GVP and GxP Systems Quality Audit SME.

A Day in the Life

• Develop and maintain Quality Performance Metrics in alignment with KPIs listed in the contractual obligations with the clients.
• Assesses the need for and assists in the development of robust and achievable CAPA plans, approves and monitors the CAPA plan timelines for completion.
• Provides oversight, coordination, and support for external Patient Support Program & PV audits and GVP inspection activities in collaboration with the Scientific Affairs Manager and Program Manager.
• Maintain accurate and timely documentation of QA auditing activities.
• Mentors QA colleagues and takes interest in their growth and development.
• Plans, leads, and conducts internal self-inspections including any risk-based audits.
• Leads the completion of PV Compliance and Vendor Qualification Questionnaires received from Pharma partners.
• Owns the self-inspection SOPs and associated Audit Checklists.
• Performs other quality and compliance related division wide duties as assigned.
• Provides responsive and proactive quality and compliance guidance to internal cross-functional stakeholders.
• Maintains key audit/inspection readiness documents to ensure the most up-to-date version and correct documents are available in the repository at all times.
• Develops an internal annual self-inspection plan based on a risk-based approach.
• Must be able to interact with all levels of internal stakeholders and build a good rapport with internal stakeholders.
• Conducts internal audit of quality systems, process improvement initiatives, patient support programs, and pharmacovigilance processes as per the annual self inspection-audit plan.
• Monitors Health Canada regulatory and quality requirements and proactively adapts the internal processes to meet the changing requirements.
• Leads Audit do’s and don’t training to prep the internal teams for external audits and inspections. Be responsible for the following external audit and self-inspection readiness-related activities:
• Identifies potential areas of compliance vulnerability with respect to quality systems and processes and communicates risk to the leadership team.
• Presents Quality KPIs to the leadership team on a set frequency.
• Lead coordination of internal self-inspections and provide support with the coordination of external audits including but not limited to audit scheduling, pre-audit training, logistics, audit runner, document follow-up, and CAPA plan & tracking.
• Oversees the maintenance of the BSRx-PSS Quality Manual for procedural updates and audit readiness.
• Work closely with the Quality event (process deviation) owners to make sure Quality events are properly documented in the system, Root Cause Analysis (RCA) for non-conformances/deviations is conducted appropriately, and Corrective and Preventive Actions (CAPA) are simple, effective and achievable.
• Utilize technical and business writing skills to effectively communicate process changes across the Specialty Program Portfolio.
• Educates internal teams on quality events/deviation types, on conducting root cause analysis, investigations, and writing effective CAPAs.

What You Bring to the Team

• Effective technical writing skills in writing policies, standard process documents, work instructions, etc.
• Knowledge of GDP (Good Documentation Practices), GMP (Good Manufacturing Practices), Health Canada GVP (Good Pharmacovigilance Practices), and ASQ guidelines.
• Experience working in a Pharmaceutical GMP environment.
• Project Management expertise and key account management.
• Knowledge of current Pharmaceutical Quality Systems and Compliance standards.
• Experience working with Quality Systems including but not limited to: Document Management Systems, Change Control Systems, and Quality Management Systems.
• Well-versed with GxP documents and audits.
• Bilingual (French/English) is an asset.
• Experience in handling internal and external Pharma audits and/or board of health inspections, including but not limited to GVP inspections.
• Experience in CAPA planning and follow-ups.
• Professional degree and/or advanced background in Health discipline and/or equivalent combination of education and experience.
• Effective business writing skills are required.
• Minimum five (5) years of previous experience working with Quality initiatives in a healthcare setting.
• ASQ Quality certification or equivalent certification is a must.
• Pharmacovigilance Certification is an asset.
• Experience using the Trackwise QMS system.