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.
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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.
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL Seqirus employee.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
Watch our 'On the Front Line' video to learn more about CSL Seqirus