Senior Director, Global Engineering Quality

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

For our site in Bern (Or Marburg/Germany, Kankakee/USA ) and within the Global Quality Operations business unit, we are looking for a:

Senior Director, Global Engineering Quality

Reporting to the VP Quality Operations , the Head of Engineering Quality Assurance will be responsible for the Quality oversight and decisions for all of the investment capital projects, validation and technology transfers, and associated regulatory submissions as well as the quality oversight for life cycle management of our products. You will be accountable for process and product quality at each stage of the product life cycle until commercialization.

You will have demonstrated strong technical knowledge, cGMP compliance and Quality by Design execution but also experienced in regulatory strategies and submissions for new products and technology transfers and have experience in associated regulatory inspections and will be responsible for Quality standards and systems aligned with the Engineering function

You will be a member of the Operational Quality Leadership Team and the Engineering Council and will be the Quality partner to the Global Head of Engineering and work closely with members of the Global Engineering Leadership Team. As part of a global organization, the position does require approximately 20% travel. Team members will be located across all CSL Behring sites. The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.

Responsibilities:

Provide Quality Assurance Oversight including issue and Risk Management for all capital investment projects

• Collaborate with internal partners for the execution of all capital projects to deliver projects on time and to the required standards
• Provide a consistent quality approach to facility, equipment and process design and development for capital
• Responsible for Quality decisions for capital projects, including consultation with local Quality leaders
• Support regulatory document submissions and pre-approval inspections for capital projects
• Support vendor qualification, for capital and other engineering investments

Provide Quality Assurance Oversight including issue and Risk Management,for all technology transfers and validations

• Collaborate with internal partners for the execution of all technology transfers and associated validations to deliver these changes on time and to the required standards
• Provide quality oversight and support to all routine validation activities
• Responsible for Quality decisions regarding technical transfers and validations, including consultation with local Quality leaders
• Support regulatory document submissions and regulatory inspections for technical transfer and validation activities
• Provide risk assessments for product quality and compliance and escalate and mitigate risks appropriately

Provide Quality Assurance Oversight including issue and Risk Management for all process engineering and product life cycle management processes

• Partner with the Global Heads of Process Engineering to ensure robust product life cycle management strategies in place to maintain product quality
• Responsible for Quality input to Quality by Design principles and processes within R&D product and process development and process engineering
• Responsible for Quality input to CPV strategy and processes for all CSL products
• Supports global process, technology and product owners for product life cycle management
• Responsible for Quality input related to Process & Technology innovation (ie process small scale and computer simulation integration, integration of process analytical technology, external partner technology integration)

Provide Quality Assurance Oversight for Engineering Standards & Engineering Documentation and Knowledge Management

• Support the development and implementation of global engineering standards and processes consistent with regulatory requirements and industry standards
• Support the set up and maintenance of an appropriate Documentation and Knowledge Management system for the Engineering function

Provide Leadership to the Engineering Quality Team:

• Provide leadership and guidance to the team of Engineering Quality SMEs based at the manufacturing sites to effectively executive on Quality Assurance oversight related to capital projects, validation and technology transfers and life cycle management of our products
• Set objectives and provide clear direction for execution by the SMEs with respect to Engineering Quality

Member of the Quality Operational Leadership Team and Global Engineering Council

• Participate at a senior Quality level in the Global Engineering Council
• Leads Quality Management Review for Engineering systems
• Member of the Quality Operational Leadership Team across all manufacturing and engineering

Provide Engineering Quality Assurance team leadership

• Provide leadership and guidance to a global team of Engineering Quality Assurance professionals
• Set objectives and provide clear direction for execution.
• Responsible for organizational design and staffing decisions
• Recruit, retain, train and develop the Engineering Quality Assurance team.
• Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve

Your profile:

• Degree in engineering and/or life sciences ; Advanced degree preferred
• Minimum of 12 years' experience in a pharmaceutical or Bio pharmaceutical Company in roles with increasing responsibility in either coming from Quality Management with knowledge in engineering or from Engineering with good knowledge in Quality Oversight
• Minimum 8 years of managerial experience
• Direct experience of QA oversight of validation, technology transfers and capital engineering projects
• Direct experience executing Quality Assurance function and system within a manufacturing and/or engineering context
• Experience in interacting to regulatory authorities including submissions and inspections
• Proven ability to build, mentor and grow a high performing team
• Ability to influence and motivate others while maintaining a cohesive team environment
• Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills
• In-depth knowledge of cGMP's, FDA, TGA, EU and other relevant GxP regulations
• Knowledge of auditing practices and procedures
• Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.