Associate Director, Reliability and Product Improvement

Job Description:

The engineering Associate Director of Sustaining Engineering is a new role within CSL's Drug Delivery Systems & Packaging (DDSP).

This role will provide technical leadership to support marketed combination products. The individual will work with DDSP and peer departments, e.g., Quality Assurance, to implement changes and improvements to combination products to ensure safety and reliability.

Changes may include process optimization, CDMO evaluation, tech transfers, supplier-related changes, and risk management updates.

This role will also identify and leverage best practices supporting the needs of a diverse combination product portfolio as well as formalizing and standardizing approaches.

This role serves as a key interface between DDSP, project teams, External Organizations, Commercial, and corporate initiatives for scoping and vetting design improvement projects.

Responsibilities:

• The role ensures all sustaining activities are conducted in compliance with applicable standards and regulations including ISO 13485, ISO 14971, 21 CFR Part 4, QMSR, and 211, and relevant ICH guidelines.
• Partner with manufacturing, CDMOs, and quality to drive design improvements, process optimizations, and supplier changes through the appropriate change control and regulatory pathways.
• The Associate Director represents the function in cross-functional program teams, design reviews, and regulatory interactions, providing expert input on device reliability to Health Authority submissions (e.g., NDA/BLA device sections).
• The Associate Director supports regulatory audits and inspections and maintains a deep understanding of the evolving combination product regulatory landscape.
• Monitor and provide input into product complaint process to identify opportunities for improvement.
• Provide key insights and lessons learned to educate new product development leads on best practices.
• Utilize technical project management skills, including resource planning, work planning, risk management, prioritization, conflict management, change management, issue resolution, and progress reporting.
• Responsible for identifying and implementing requirements for safety, quality, and reliability are effectively met for CSL commercialized combination products.

• Bachelor's in engineering (mechanical or chemical preferred)
• Minimum 10 years of experience in either parenteral or device manufacturing in the pharmaceutical space
• Leadership experience in team management or supervision

• Experience with manufacturing processes, validation practices, and cGMP guidelines
• Knowledge of process automation and equipment reliability
• Ability to collaborate with internal teams, CMs, and contractors