Senior Manager, CorpQualAud-ARPL-CQA AR

Job Summary

Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem Group of Companies’ suppliers encompassing audit scheduling, execution, reporting, follow-up and closure of the audits. Accountable for adhering to the requirements of the Apotex’s Quality Manual, policies, procedures; and applying all regulatory standards such as ISO, Health Canada, FDA, EU/EMEA, MHRA, PIC/s, ANVISA and TGA, when conducting audits. Responsible for recommending audit system enhancements based on the learnings leveraging the existing system/field experience and collaborating with management to ensure continuous compliance, development & improvement of the Corporate Quality Audit program.

Job Responsibilities

• Execute Corporate and supplier audits such as first GMP, routine, Targeted Technical Assessment (TTA) and For-Cause audits in accordance with Apotex’s SOPs and current GMP regulations
• Adopt the best practices of Excellence in Partnership to develop and sustain effective relationships with Apotex sites, suppliers, contractors, and business partners
• Perform Due Diligence audits of potential new Apotex suppliers, generate reports and provide recommendations pertinent to suitability and sustainability of the quality and compliance of new suppliers. Propose remediation plans to mitigate risks that could be impeding the future stability of Apotex supply chain
• Liaise with Apotex Enterprise sites to evaluate the leading indicators such as QPIs prior to conducting site audits to ensure high risk areas are included as part of the site audit scope. Communicate potential non-compliance aspects of the audit outcome with the applicable site leadership team and escalate to Apotex Escalation Committee (AEC) as appropriate
• Research and compile all available supplier quality/procurement data such as complaints, investigations/deviations, recalls in Apotex systems (SAP, QMS TW, LIMS, etc.) and external systems (e.g. Health Canada, FDA, MHRA websites) to ensure high risk areas are included as part of the audit scope.
• Perform Risk Profiling of Apotex suppliers for Predictive Analytics to determine the audit frequencies based on the risks
• Compile precise, accurate and chronologically factual audit reports within the allotted time to enable meaningful review and approval of the audit reports
• Communicate the identified deficiencies and compliance risks to appropriate business stakeholders such as Global Active Pharmaceutical Ingredients (GAPI), External Manufacturing Quality (EMQ), Supplier Quality (SQ), Business Development (BD), Apotex Site Heads and Global Supply & Technical Operations (GSTO)
• Support the sites with developing and executing remediation actions to drive sustainable compliance to regulatory and Apotex’s standards. Evaluate the appropriateness of proposed CAPAs and remediation plans, monitor the progress and evaluate the effectiveness of the CAPAs implemented
• Provide authoritative technical and regulatory guidance/direction to internal and external stakeholders pertinent to regulatory compliance
• Provide expert inspection and logistics support during inspections of Apotex sites by regulatory agencies and customers when requested
• Prepare, update and review proposed changes to SOPs
• Share knowledge, collaborate with auditors across the regions to enhance expertise in different disciplines and to mentor/coach new & existing auditors
• Review emerging/ever-changing regulatory landscape, standards & inspection trends to stay a step ahead of the regulators in protecting Apotex’s interests internally and externally
• Fiscally responsible for spending in accordance with company policy and to accomplish budget targets favourable to plan
• Accountable for meeting individual and departmental monthly, quarterly and yearly audit metrics
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • University degree in science or Regulatory affairs related program
  • Background in pharmaceutical/chemical sector would be an asset
• Knowledge, Skills and Abilities
  • Excellent knowledge in current good manufacturing regulations and standards as applicable to the pharmaceutical industry such as ISO, Health Canada, FDA, EU/EMEA, MHRA, PIC/s, ANVISA and TGA
  • Expertise in at least one specific area: non-sterile manufacturing, sterile manufacturing, biopharmaceuticals, medical devices, API, excipients and intermediates is preferred.
  • Ability to review and comprehend the requirements of ICH, WHO, EXCiPACT, ISO, IPEC, ISPE, etc. guidance documents
  • Clear and concise written and verbal communication in Apotex’ s language of business
  • Demonstrated organizational skills and strong attention to details
  • Demonstrated ability to effectively manage multiple priorities in a fast-paced environment
  • Demonstrated ability to exercise discretion, maturity, good judgement and maintain strict confidentiality when exposed to, and handling, sensitive and confidential information
  • Work independently or in a team setting to achieve individual, departmental and organizational goals
  • Advanced computer skills, including Microsoft Office Products
  • Working knowledge with electronic Enterprise systems such as Quality Management System TrackWise (QMS TW), Systems Applications and Products (SAP) and Laboratory Information Management System (LIMS) would be an asset
• Experience
  • Minimum 10 years of relevant experience in the Pharmaceutical industry with a minimum of 5 years spent in Quality operations, Quality Assurance and Quality Audits
  • Working knowledge and/ or hands-on experience with the other Pharmaceutical Quality Systems would be an asset