Senior Director, Quality Control Operations

In this role, you will be reporting to the CSL Global Head of Quality Control who will provide strong leadership and strategic direction to the quality control organization as well as building and maintaining a strong quality culture within CSL.

In this position you will manage, direct and maintain the company's global operational quality control laboratories to ensure GxP compliance with all testing requirements of raw materials, components, intermediates and final products originating internally or from external vendors (CMOs) and or suppliers.

You are responsible for proactively managing and implementing global quality control processes and procedures assuring that all testing facilities, globally, are in compliance with appropriate Quality systems.

You have demonstrated strong technical knowledge and cGxP compliance as it relates to laboratory and stability functions.

You also have demonstrated experience in the Pharmacopoeial testing, preparing and complying with required regulatory guidelines and inspection readiness and action planning.

This position will be based at one of the CSL manufacturing sites. The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.

Role and responsibilities:

Lead best practice global Quality Control processes and procedures.

• Drives global QC processes and procedures consistent with regulatory requirements and corporate standards.
• Provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
• Ensure robust measurement and reporting tools are developed to enable accurate and timely reporting.
• Ensure collaboration across the CSL network to share and implement best practices.

Provide Quality Control Execution and Oversight

• Collaborate with partners to enable compliant, timely and successful quality control testing ensuring all program and corporate goals are met.
• Partner with all functions to proactively identify and mitigate Quality Control issues/concerns.
• Oversee the operations of all Quality Control activities globally for testing activities.
• Lead and/or review key global laboratory deviation evaluation and resolution activities as required.

Continuously improve quality control processes to reduce cost and improve quality.

• Collaborate with business partners including quality's corporate quality leaders, manufacturing site functional leadership, global supply chain leadership, R&D, and others to identify improvement opportunities across the organization.
• Optimize in-process and final quality control/inspection efficiency.
• Work with operations leaders and team members to define the implementation strategies for continuous improvement across the organization.
• Develop appropriate tools and methods to sustain improvements across the organization.

Provide Quality Control team leadership.

• Provide leadership and guidance to a global Quality Control site heads to effectively execute on Quality Control strategies and programs.
• Set objectives and provide clear direction for execution.
• Responsible for organizational design and staffing decisions.
• Recruit, retain, train, and develop the Quality Control team.

Quality Issue and Risk Management

• Lead proactive risk assessments to identify and mitigate quality control issues
• Represent CSL during audits and inspections, as needed
• Ensure inspection readiness across the QC network

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.

Background education and past experience

• Advanced degree (Master's) in life sciences field; PhD preferred.
• Minimum of 12 years' experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality management.
• Minimum 10 years of managerial experience
• Experience working in a highly regulated GMP environment as it applies to laboratory and stability functions
• Experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up.
• Experience with testing methods and processes including raw materials testing, stability testing, and sample management.
• LEAN experience, preferred.

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.