Associate Director, Combination Products

Apotex; Toronto; On-site; CAD 100,000 - 150,000; Full time

Job summary

A global health company in Toronto seeks an Associate Director for Combination Products to oversee quality aspects of drug-device combinations. This role ensures compliance with regulations and leads the development of quality management systems. The ideal candidate has a B.Sc in a life science and at least 10 years of experience in quality assurance and operations, particularly in a GMP environment. Strong interpersonal skills and a commitment to high performance are essential.

Benefits

Accommodation for applicants with disabilities

Qualifications

• 10 years of combined experience in Quality Assurance and Operations and/or R&D.
• Extensive experience in a GMP regulated environment with specific experience in combination product development.

Responsibilities

• Oversee quality aspects of drug-device combination products.
• Ensure compliance with regulatory requirements for combination products.
• Develop and maintain quality management systems.
• Lead and participate in design control activities.
• Manage quality investigations and implement corrective actions.
• Represent the company during regulatory inspections.

Skills

Strong knowledge of relevant regulations

Quality systems

Risk management principles

Design control processes

Pharmaceutical processes and equipment

Excellent oral and written English communication skills

Interpersonal savvy

Ability to analyse process improvements

Education

B. Sc in a life science

Job description

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary

The Associate Director, Combination Products oversees the quality aspects of products that combine drug, device and/or biological products. This role is crucial in ensuring the safety, efficacy and quality of complex products. The incumbent ensures compliance with regulatory requirements for combination products and devices including design control, risk management and the manufacturing process throughout the product lifecycle, from development to post market surveillance. The incumbent works closely with Apotex, its Contract Manufacturing Organizations, relevant third party suppliers (i.e. Constituent suppliers) and internal stakeholders to ensure compliance.

Job Responsibilities

• Responsible for developing, implementing and maintaining quality management systems specific to combination products, ensuring they align with regulatory requirements and other applicable standards from early phase through commercialization for combination product dosage forms such as sterile pre-filled syringes, pen devices, auto-injectors, topical pumps, nasal delivery devices, inhalation products, ophthalmics.
• Maintain and improve quality systems in alignment with combination product requirements under 21 CFR Part 4, QMSR, ISO 13485, and other regulations
• Leading or participating in design control activities, risk assessments and developing risk management plans for combination products
• Participates on cross functional teams to bring combination products through the Design Control process to deliver on time submissions and launches.
• Review and approve technical protocols, reports and design control documentation.
• Leading or supporting investigations into quality issues, including deviations, complaints, and non-conformances related to the combination product, and implementing corrective and preventative actions.
• Represent Apotex during regulatory inspections as the subject matter expert for combination products
• Supports the audit team as an SME as it relates to combination product and device requirements. Provides support for quality audits and due diligence activities.
• Leads and manages pre-approval inspection readiness as it relates to combination product inspections.
• Participates in Management reviews to identify and address quality and operational issues as it relates to combination products
• Participate and lead performance conversations with employees, including monthly one-on-ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

Job Requirements

Education B. Sc in a life science

10 years of combined experience in Quality Assurance and Operations and/or R&D

Knowledge, Skills and Abilities Strong knowledge of relevant regulations, quality systems, risk management principles, design control processes, including a familiarity with medical device regulations in the relevant markets

Knowledge and experience in pharmaceutical processes and equipment

Demonstrated ability to instil a culture of high performance, accountability, and quality.

Demonstrated interpersonal savvy and relationship management / networking skills

Strong ability to deal with ambiguity and manage through difficult situations

Thorough knowledge of applicable regulatory requirements

Excellent oral and written English communication skills

Ability to analyse and implement process improvements

Experience Extensive experience in a GMP regulated environment with specific experience in combination product development, device quality or device development is required.

Demonstrated track record of successfully building or sustaining combination product compliance systems for pharmaceutical or medical device industry.

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.