VP, Regulatory & Quality

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. 

We are committed to delivering high-quality, compliant products and services that meet the highest industry standards. As we continue to grow, we seek an experienced Vice President, Regulatory & Quality (VP, R&Q) to lead our regulatory affairs and quality assurance functions.

The VP, R&Q will lead the strategic direction and execution of regulatory and quality initiatives across the organization as well as provide regulatory strategy and support for API’s clients and incubated companies. This role will drive compliance, risk management, and regulatory strategy to ensure API adhesion to relevant industry standards, regulations, and guidelines. The VP, R&Q will work closely with cross-functional teams, government agencies, and regulatory bodies to develop and implement quality and compliance strategies that support API’s mission and growth objectives.

As part of a growing team within API the VP, R&Q will work with various existing and early-stage systems with the goal of building the organizational-wide systems.

** Please note this position is flexible and eligible for remote/hybrid work arrangements.

Key Responsibilities, include but are not limited to:

Strategic Leadership

• Develop and execute the regulatory and quality assurance strategies (GCP) that align with business objectives and comply with local, national, and international regulatory requirements.
• Advise executive leadership on regulatory and quality compliance, emerging industry trends, and risk mitigation strategies.
• Serve as the primary contact for regulatory authorities and agencies, including Health Canada, the FDA, and the EMA, leading all interactions, submissions, inspections, and approvals.

Regulatory Affairs Management

• Develop and oversee global regulatory strategies, policies, procedures, and processes to maintain compliance with applicable regulations (e.g., HC, FDA, EMA, ISO, etc.) supporting product development, clinical trials, and market expansion across various regions, including North America, Europe, and other key markets
• Collaborate with clients, R&D, clinical, manufacturing, quality, and commercial teams to ensure regulatory requirements are integrated into product design, development, commercial strategies and lifecycle management.
• Ensure timely and successful submissions of regulatory filings, licenses, and registrations in support of product approvals and commercial launches (prescription & non-prescription drugs, vaccines, medical devices and natural health products).
• Address any regulatory queries promptly to facilitate smooth approval processes and maintain timelines.

Quality Assurance Oversight

• Oversee the development, implementation, and continuous improvement of a comprehensive Quality Management System (QMS) that supports, GCP, and GLP.
• Lead quality audits, inspections, and compliance activities, and address findings and corrective actions with appropriate teams.
• Oversee supplier qualification and auditing programs to ensure compliance with quality standards and regulatory requirements.
• Provide guidance on quality aspects of clinical trials, product specifications, and manufacturing protocols to meet regulatory and quality standards.
• Drive continuous improvement initiatives, implementing proactive measures to enhance quality in the GCP area.

Team Development and Cross-Functional Collaboration

• Build and lead a high-performing regulatory and quality team (GCP), providing mentorship, development, and clear performance goals.
• Foster strong cross-functional collaboration with R&D, Manufacturing, Marketing, and other teams to ensure compliance and quality from concept to commercialization.
• Drive a culture of continuous improvement and quality excellence throughout the organization.

Risk Management and Compliance

• Proactively identify regulatory risks and develop mitigation plans to ensure timely approvals and market entry.
• Maintain and update knowledge of regulatory requirements, ensuring the company is up to date with new laws and regulations affecting product lines.
• Oversee all regulatory and quality-related documentation, records, and reporting to ensure compliance with regulatory standards and internal policies.

Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)

Education

• Bachelor’s degree in a relevant scientific discipline (e.g., Pharmacy, Biology, Chemistry). Advanced degree (MS, PhD, PharmD) preferred.

Experience

• Minimum of 15 years of experience in regulatory affairs and quality assurance, with a proven track record in a leadership role, in relevant industry, e.g., pharmaceuticals, biotech, medical devices.
• Strong knowledge in GCP and Quality systems to develop drug products in clinical phases for non-sterile and sterile drug products including mRNA, Peptides and Biologics
• Experience in GMP manufacturing of parenteral, sterile and oral pharmaceutical products.
• Extensive knowledge of regulatory standards and requirements (FDA, EMA, HC, ISO, etc.) and experience with submissions and product approvals.
• Strong understanding of Quality Management Systems (QMS) and hands-on experience with quality assurance processes, risk management, and continuous improvement.

Personal Competencies

• Exceptional communication, leadership, and team-building skills.
• Ability to work cross-functionally and influence without direct authority in a dynamic, fast-paced environment.

Working Conditions

• Required travel between Edmonton API sites.
• Possible exposure to chemicals, machinery, or equipment.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.

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.

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 the interest of all applicants but 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 HR department.
• 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: November 28, 2024