Manager, Supplier Qualification(Auditor)

Applied Pharmaceutical Innovation (API) brings life-saving 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 Canada's 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 risk-based auditing methodologies to drive compliance, enhance quality standards, and mitigate organizational risks.

Please note this position requires full-time on-site presence.

Key Responsibilities

• 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 follow-up 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.
• Provide 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 planning, execution, findings, completion and tracking.
• Develop and implement strategic, risk-based 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 execution.
• 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 non-compliance issues.
• Perform trend analysis on audit findings, providing data-driven 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 company's audit strategies remain current and effective.

Qualifications

Education

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

Experience

• At least 8-10 years broad experience in the pharmaceutical industry.
• 4 years auditing experience required, and excellent knowledge of regulatory requirements.
• Expertise in at least 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 GUI-0001, GUI-0050, GUI-0104, GUI-0119, 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 issues.
• Compliance Risk/ Risk Management, Continued Learning, Dealing with Ambiguity, Decision Making Skills, Organizational Skills, Self-Awareness, Technological Expertise.
• Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with colleagues, vendors and customers.
• Sound and practical judgment 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 well-being 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 everyone's contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life 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 well-being 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 careers@appliedpharma.ca.

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 pre-employment screening, which includes background reference checks, educational credential verification, and criminal reference checks.

Application Deadline: May 6, 2025