Associate Director, R&D QA Clinical Trial Material - mRNA

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!

Job Summary

This position is responsible for a multi-disciplinary team including managers and senior professionals providing frontline Quality Assurance (FLQA) oversight of in-house GMP manufacturing operations for bulk and fill finish production activities in the Small Scale Filling (SSF) area in Holly Springs and batch disposition of materials used in GMP manufacturing in the SSF and bulk and semifinished products for clinical trial material (CTM) to ensure compliance with applicable regulatory filings, cGMP regulations and data integrity, and provide QA oversight of changes and deviations. The position fosters strong collaboration with senior business partners in order to plan and coordinate activities required to deliver the fiscal year objectives with regard to manufacturing for products in clinical development. As needed the position will also partner with team members in R&D QA to support QA oversight of clinical packaging at third parties and final clinical batch release and continuous improvement efforts globally.

Principal Accountabilities

Responsible for developing and implementing Quality Assurance Systems for FLQA oversight and clinical batch release to ensure compliance with company standards and regulatory guidelines as applicable to manufacturing for clinical trails and associated GMP systems (ICH Q10):

• Ensures the principles of quality risk management (ICH Q9) are used in a phase appropriate manner to monitor, identify and control risks to data integrity and product quality during GMP production activities

• Ensures existing systems to manage change, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities are leveraged as applicable to area of oversight

• Provides direction for changes, complex deviations, failures to meet acceptance criteria, shipping excursions, product technical complaints and CAPAs as well as understanding the specific impact on R&D activities and applicable products

• Ensures the provision of accurate and timely reports on findings, risks and trends stemming from deviations for management review

• Proposes and/or implements improvement initiatives

Maintains GMP-related quality systems including standard operating procedures (SOPs) and supportive systems to ensure cGMP compliance related to clinical manufacturing activities and clinical batch release

• Defines procedures governing quality systems processes: document management, change control, deviation handling, product technical complaints, supply recovery, training and audit management

• Defines and maintains phase appropriate Quality standards governing the life-cycle for development of products across all projects/programs

• Reviews and approves SOPs, Work Instructions, batch production records and other procedures, ensuring compliance with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.

Manages GMP systems for timely release of Seqirus products to clinical trials through personnel management and plans for how to deliver the fiscal year objectives:

• Serves as R&D QA point of contact for area of oversight

• Drives achievement of Quality performance expectations for the year through leadership of direct reports, while overseeing R&D GMP regulated processes and supporting activities throughout the business

• Recruits, motivates and develops a high performing R&D QA Clinical Trial Material group with focus on commitment to achieving high quality deliverables with a culture of collaboration

• Acts as a Release Responsible Person (RRP) as needed

• Establishes teams as required to provide QA oversight to GMP clinical manufacturing activities, and leads those teams to:

  • Ensure as applicable that clinical manufacturing activities are compliant with GMP and meet data integrity requirements on an ongoing basis

  • Review and approve Technical Protocols, Technical Reports, Risk Assessments, associated documentation, etc. for compliance and completeness

  • Provide on-the-floor QA oversight to GMP manufacturing activities in-house, and liases with QA at third parties as needed

  • Provide QA oversight of deviations and changes related to clinical manufacturing globally

  • Investigate and QA-approve product technical complaints for clinical trial material globally

  • Perform release of materials, bulk, semifinished and final clinical trial material as Release Responsible Person (US) or Authorised person (Australia), and provides all documentation necessary to facilitate QP release in EU

  • Partner with TD, MS&T in the technical assessment of whether material suppliers and Contract Development and Manufacturing Organizations (CDMOs) are fit for purpose

  • Perform or otherwise arrange audits to support qualification and monitoring of CDMOs for GMP manufacturing of clinical material, coordinating with R&D QA Systems to establish Quality Agreements, complete change control, etc.

  • Work with TD/MS&T, QC and Supplier Management to enroll materials for use in GMP production

Ensures preparation, successful conduct and follow-up of all regulatory inspections, self inspections and customer audits

• Ensures internal audits, self inspections and mock recalls are conducted to ensure R&D quality systems are operated in accordance with established procedures and GMP, prepares for regulatory inspections and serves as subject matter expert for applicable area of oversight

• Leads inspection finding responses related to applicable area of oversight

• Ensures the provision of accurate and timely reports on audit findings, risks and trends stemming from audits, inspections and mock recalls for management review

Collaborates cross-functionally to help others understand quality expectations, facilitate quality assurance training and communicate best practices

• Represents R&D QA in tactical execution forums for process/projects as needed, ensuring quality expectations are understood and R&D QA activities are coordinated with those in other functions for the fiscal year

• Provides advice, review and approval of key aspects of GMP manufacturing approach (e.g., specifications, tech transfer plans, control strategy, QbD elements such as QTPP, CQA and CPP assessments, combination product design, stability plans, etc.)

• Ensures proper knowledge transfer during Technical Transfer to manufacturing sites

• Ensures evaluation of QA impact of new or updated regulations (local and global) and the implementation of the regulations into the R&D quality management system; communicates upcoming changes to other functions that may be impacted, seeking alignment

Other responsibilities may include:

• Contributes to budget and objective planning for the upcoming fiscal year as needed

• Supports R&D and Quality system and process improvement initiatives

• Maintains required knowledge of applicable regulations, guidelines and company standards and procedures

Qualifications

• Bachelor’s degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred.

• 8-10 years’ experience in quality/GMP in the pharmaceutical/biotech industry including 3+ years’ leadership/team management experience

• Experience with regulatory authorities and international inspections

• Demonstrated success in project management and business/QA systems

• Experience within a global matrix organization

• Knowledge of GMP, preferably through different phases of development and in different market areas