Head, Clinical QC
With operations in 35+ nations and ~27,000 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 one of the largest influenza vaccine companies 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!
Reporting to the Global Head of Quality Control, the Head of Clinical QC will provide strong leadership and strategic direction to the Seqirus organization as well as building and maintaining a strong quality culture. This global position will manage, direct, and maintain the GMP testing support for all Seqirus clinical programs to ensure GxP compliance with all testing requirements. The responsibility of the position is to support all clinical trial GxP testing needs including clinical raw materials, components, intermediates, drug substance, final products, and stability originating internally or from external contract manufacturing operations (CMOs) and or suppliers. This individual is responsible for proactively managing and implementing global quality control processes and procedures assuring that all clinical testing facilities, globally, are in compliance with phase appropriate Quality systems.
The incumbent will have demonstrated strong technical knowledge and cGMP compliance as it relates to clinical laboratory and stability functions. This individual will 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 in Holly Springs, North Carolina. The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization. The collaboration and coordination is significant given the variety of stakeholders and the innovative nature of the role.Major Responsibilities:
Implement and ensure adherence to phase appropriate clinical Quality Control processes and procedures
- Implement GxP clinical testing processes and procedures consistent with regulatory requirements and corporate standards for clinical testing.
- Provide QC oversight and approval of GxP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
Provide Quality Control Execution and Oversight for Clinical testing
- Collaborate with internal and external partners to enable compliant, timely and successful testing, supporting clinical product release, and lifecycle management, ensuring all program and corporate goals are met.
- Provide technical leadership for the team, implementing new technologies, advancing assay development and qualification throughout the clinical lifecycle, and documenting assay lifecycle
- Partner with all functions to proactively identify and mitigate issues/concerns
- Oversee the operations of all clinical Quality Control activities for internal and external testing activities.
- Conduct laboratory deviation evaluation and resolution activities as required
- Represent the Quality Control organization in interactions with other key functional units as well as with external contract testing laboratories.
Continuously improve quality control processes to reduce cost and improve quality
- Collaborate with business partners including quality leaders, functional leadership, clinical supply chain leadership and others to identify improvement opportunities across the organization.
- Optimize quality control efficiency.
- Recommend appropriate tools and methods to sustain improvements across the organization.
Provide Quality Control team leadership
- Provide leadership and guidance to a clinical Quality Control team to effectively execute on Quality Control strategies and programs.
- Provide technical leadership for the phase appropriate quality system for testing clinical trial materials
- Set objectives and provide clear direction for execution.
- Responsible for organizational design and staffing decisions.
- Recruit, retain, train and develop the 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.
Quality Control Issue and Risk Management
- Lead proactive risk assessments to identify and mitigate quality control issues
- Represent Seqirus during audits and inspections, as needed
- Ensure inspection readiness across the QC network (internal and external)
- Ensures and may participate in regular GxP audits of testing laboratories.
- Serves as the local SME for analytical methodologies, specifications, stability, reference standard, etc. during regulatory inspections.
- Bachelor’s degree in life sciences required; advanced degree preferred
- Minimum of 10 years’ experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality management.
- Minimum 8 years of managerial experience preferred
- 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.
- Experience with assay methodologies and validation techniques.
- Experience with implementing root cause analysis and effective investigation practices.
- LEAN experience, preferred
- Proven ability to build, mentor and grow a high performing team.
- Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills
- In-depth knowledge of cGMPs, FDA, TGA, EU, pharmacopeia, and other relevant regulations
- Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators
- Ability to influence and motivate others while maintaining a cohesive team environment.
- Skills in GMP manufacturing and highly regulated environment