Associate Director, Reliability and Product Improvement

Job Description:

The engineering Associate Director of Sustaining Engineering is a new role within CSLs 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 ISOCFR 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.

Basic Qualifications

• Bachelors 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

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

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