Associate Director, Combination Products

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 products may be produced by Apotex or by a third party manufacturers. The Associate Director 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 imcumbent works closely with Apotex, it’s Contract Manufacturing Organizations, relevant third party suppliers (ie. 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, nasals delivery devices, inhalation products, opthalmics.
• 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 dlligence 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
  • Extensice 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.