Manager Supplier Qualification Auditor

Applied Pharmaceutical Innovation (API) brings lifesaving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven compassionate and laser focused on making a dramatic positive impact with everything we undertake.

When you join API you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries increasing the amount of commercial research and development in the country and supporting Alberta as a key pillar in Canadas life sciences sector.

The Manager Supplier Qualification (Auditor) plays a critical role in ensuring adherence to company policies Quality Agreements GMP guidelines and global regulatory requirements governing GMP activities. This position requires a deep understanding of regulatory frameworks and riskbased auditing methodologies to drive compliance enhance quality standards and mitigate organizational risks.

** Please note this position requires fulltime onsite presence.

Key Responsibilities include but are not limited to:

• Lead and execute comprehensive quality GMP audits in accordance with regulations and standards governing GMP (including internal audit vendor audit and site audit) to assess adherence to regulatory standards company policies quality agreements and guidance documents.
• Establishment of Quality Agreements with Customers Material Suppliers Packaging Components Suppliers QC Laboratory.
• Ensure appropriate escalation to responsible management in case of critical findings and support immediate followup measures according to Active Pharmaceutical Innovation (API) requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
• Material qualification: Based on Risk management including risk assessment for residual solvents Degradation products Elemental impurities Nitrosamine chemical and microbiological contaminants.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
• Provides constructive evaluation of quality related system investigations including manufacturing sites
• Maintain current knowledge of regulations standards and guidance documents.
• Use of electronic audit system for audit plaining findings completion and tracking.
• Develop and implement strategic riskbased audit plans to proactively identify areas of concern and ensure regulatory compliance
• Provide expert consultation on GMP requirements and quality assurance strategies guiding both internal and external stakeholders
• Coordinate and conduct supplier sites audit in collaboration with project plans management teams and ensuring efficient and effective audit
• Analyze and interpret audit findings to author or direct the preparation of detailed audit reports identifying risks gaps and areas for improvement
• Oversee and review corrective action/preventative action (CAPA) plans ensuring timely implementation and effectiveness in addressing noncompliance issues
• Perform trend analysis on audit findings providing datadriven insights to support continuous quality improvement initiatives
• Organize and conduct mock inspections to prepare teams for external regulatory audits and identify potential compliance risks before formal inspections
• Review and approve audit reports ensuring accuracy clarity and regulatory alignment
• Stay abreast of evolving regulations and best practices related to activities to ensure the companys audit strategies remain current and effective.

Qualifications (Education Certification Degree Skills Knowledge etc.

Education

• Bachelors degree in Chemistry Pharmacy Biology Engineering or another related science
• Valid certification as Certified Quality Auditor (CQA) or demonstrated equivalent certification.

Experience:

• At least 810 years broad experience in the pharmaceutical industry.
• 4 years auditing experience required and excellent knowledge of regulatory requirements.
• Expertise in at latest three or more of the following areas: GMP Manufacturing QC Laboratories Active Pharmaceutical Ingredient manufacturing Excipients Sterile manufacturing Microbiology Computer System Validation Packaging activities Quality Systems.
• Knowledge of minimally GUI0001 GUI0050 GUI0104 GUI0119 21CFR210&211 21CFR11 and ICHQ9.
• Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
  

Personal Competencies

• Excellent verbal and written communication skills required to draft and author written documents/reports/presentations
• Strong interpersonal verbal and written communication skills including effective listening facilitating group discussions influencing without authority and providing appropriate feedback
• Ability to plan organize prioritize and manage workload independently
• Adaptable to changing environments able to think quickly able to deal with ambiguity and learn new tasks applying routine knowledge
• Superior analytical skills focusing on identifying potential compliance issues investigating root causes brainstorming and identifying alternatives and assessing the effectiveness of actions
• Proven skills in interpreting synthesizing inferring evaluating and extracting pertinent data to identify areas of risk trends and aggregated issue
• Compliance Risk/ Risk Management Continued Learning Dealing with Ambiguity Decision Making Skills Organizational Skills SelfAwareness Technological Expertise.
• Strong interpersonal skills including diplomacy and persuasion used in obtaining cooperation and consensus with colleagues vendors and customers.
• Sound and practical judgement in the interpretation and application of regulations and company standards
• Excellent oral and written English communication skills.
• Good knowledge of an additional language (e.g. German French Italian Chinese or Spanish) is a plus.

Working Conditions:

• Required travel between Edmonton API sites.
• This position requires you to be on site.
• Willingness to travel up to 50 of the time.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.
• Please attach relevant certifications or designations

Perks and Benefits at API

Comprehensive Health Coverage: At API we prioritize the wellbeing of our employees. We offer a comprehensive health coverage plan. Our premiums are 100 covered ensuring that you and your dependents receive the necessary healthcare support.

Payment in Lieu of Pension: API provides an additional 15 of your annual base salary as an alternative to traditional pension benefits.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities including training programs workshops conferences and certifications. We encourage employees to enhance their skills broaden their knowledge and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork open communication and a supportive atmosphere where everyones contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy worklife balance. API offers a generous paid time off (PTO) policy that includes vacation days medical/personal days and holidays. We encourage our employees to prioritize their wellbeing and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program which promotes the use of environmentally friendly modes of transportation. By participating in the program you commit to making green transit your primary mode of transportation for at least 75 of your commute to and from work. Green transit includes walking biking carpooling and public transportation.

Work From Home: Eligible employees are entitled to 10 Work from Home days this is subject to job function company needs and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process please contact .

Our team clients and stakeholders come from a variety of backgrounds. In recruiting for our team we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences education culture gender race sexual orientation religious or ethnic background neurodiversity and cognitive and physical ability.

Before employment successful candidates will be required to meet the requirements of a preemployment screening which includes background reference checks educational credential verification and criminal reference checks.

Application Deadline: May 6 2025