Global Director, R&D QA GLP - mRNA

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 01, 2021
Ref
R-140482
Required Education
Bachelors Degree
Position Type
Full time

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 Description

Job Summary

This position is globally responsible for multi-disciplinary teams providing Quality Assurance oversight of all R&D lab-based / small-scale activities for Seqirus (in vitro or in animals), from initial proof of concept work to work that supports nonclinical studies and clinical trials, as well as GLP nonclinical studies, clinical trial sample distribution and testing according to GCLP, GMP testing of clinical trial material, to ensure compliance with applicable regulations and data integrity, provide oversight of changes and deviations. The position fosters strong collaborations with senior business partners in order to drive innovation with new product development and provides strategic direction for continuous improvement globally.

Major Accountabilities:

Sets the strategic direction for the R&D QA oversight of GxP laboratory activities globally (managing budget, personnel management, strategic planning)

  • Drive achievement of Quality performance expectations through leadership of direct reports, while overseeing R&D GxP regulated processes and supporting activities throughout the busines.
  • Recruit, motivate and develop a high performing R&D QA GxP lab group with focus on commitment to achieving high quality deliverables with a culture of collaboration.
  • Ensure functional budgets and resource targets are assessed and managed to enable departmental targets to be achieved.

Oversee the performance of the Quality Systems as applicable to CMC and nonclinical development and associated GxP 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 lab-based / small-scale studies (in vitro or in animals), conduct of GLP nonclinical studies, distribution and testing of clinical samples per GCLP and GMP testing of clinical trial material
  • 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 and CAPAs as well as understanding the specific impact on R&D activities and applicable products
  • Ensures internal audits and self inspections are conducted to ensure R&D quality systems are operated in accordance with established procedures and GxPs, 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 metrics, findings, risks and trends stemming from audits, inspections and deviations for management review and proposes and/or implements improvement initiatives.

Establish and maintain strategic collaborations with internal and external business partners which include the R&D Leadership Team and Manufacturing Sites Ops/Quality Leadership Teams; in order to build and evolve quality related activities proactively into the design of functional area deliverables. Provide quality and compliance direction, advice and support as needed to CMC development and Research areas, continuously enabling innovation and monitoring compliance with Seqirus Quality Policies and applicable GMP and GLP requirements from discovery and pre-clinical/toxicity studies through completion of Phase 3 clinical trials and technical transfer activities.

  • Represents Quality on R&D or Global Quality process/projects as needed, helps scope out and establish strategic cross-functional plans for new initiatives and drives program of activities
  • Provides advice, review and approval of key aspects of CMC development (e.g., process and analytical development, analytics for release, in-process, stability and characterization testing, etc.) and GMP testing of clinical trial material
  • Provides advice, review and approval of key aspects of nonclinical development (e.g., primary pharmacodynamic, safety pharmacology, toxicokinetic, pharmacokinetic and toxicology studies, release of material for GLP toxicology studies etc.)
  • Establishes, maintains and provides direction for phase appropriate Quality standards governing the life-cycle for development of products across all projects/ programs
  • Develops and implements quality strategy for non-regulated laboratory activities, GLP nonclinical studies, GCLP clinical sample testing and GMP clinical trial material testing, which may be either internal or outsourced to CMOs.
  • Ensures proper knowledge transfer during Technical Transfer to manufacturing sites
  • Represent R&D QA on strategic cross-functional teams and decisions making boards
  • Ensures evaluation of impact of new or updated regulations (local and global) and the implementation of the regulations into the R&D quality management system.

Serves as the global R&D QA single point of contact for lab-based / small-scale activities (in vitro or in animals), GLP nonclinical studies, distribution and testing of clinical samples (GCLP) and GMP testing of clinical trial material, across all R&D programs globally and internal/external activities. Establishes teams as required at different sites to provide QA oversight to non-regulated, GLP, GCLP and GMP laboratory activities, and leads those teams to:

  • Ensure as applicable that activities in R&D are compliant with GLP, GCLP and GMP and meet data integrity requirements on an ongoing basis.
  • Review and approve SOPs, Work Instructions and other procedures for R&D activities, ensuring compliance with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.
  • Review and approve Laboratory Notebooks, Technical Protocols, Technical Reports, Risk Assessments, associated documentation, etc. for compliance and completeness.
  • Partner with TD and QC in the provision of data required for GLP nonclinical batch release and GMP clinical batch release to the Release Responsible Person (RRP) or Qualified Person (QP) as required.
  • Provide QA oversight as needed to lab-based / small-scale work (e.g., technical study execution, sample testing, sample distribution, etc.), either in-house or at third party suppliers.
  • Ensure data integrity by performing data verification checks (or ensuring these have been performed) for any data obtained from area of oversight being provided to regulatory authorities (e.g., approving data included in regulatory filings or communications with health authorities)
  • Partner with TD, Toxicology, Clinical Serology and QC in the technical assessment of whether material suppliers, CROs, Contract Development and Manufacturing Organizations (CDMOs) are fit for purpose for technical work as required.
  • Perform or otherwise arranges audits to support qualification and monitoring of Contract Research Organizations (CROs) performing GLP nonclinical studies, distribution and testing of clinical samples (GCLP), GMP testing of clinical trial material, coordinating with R&D QA Systems to establish Quality Agreements, complete change control, etc.

Other responsibilities may include:

  • Contributes to the larger strategic vision of the Quality organization and ensuring continuous alignment and improvement within the function
  • Supports R&D and Global quality system and process improvement initiatives
  • Maintains required knowledge of applicable regulations, guidelines and company standards and procedures.

Minimum Requirements:
  • Bachelor’s degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred.
  • 10+ years in the pharmaceutical, biotechnology or related industry with significant experience of working within a GxP Quality system.
  • Demonstrated expertise in GLP is essential, with experience in GCLP and/or GMP preferred as it relates to testing activities
  • 3-5 years of experience leading teams
  • Experience in laboratory work (in vitro or in vivo), preferably in an R&D environment
  • Experience of RNA-based product preferred
  • Leadership of a global team with remote direct reports would be an advantage
  • Deep understanding and demonstrated application of GLP, GCLP, GMP as it relates to new product development
  • Advanced knowledge of Small-scale, lab-based studies (in vitro and animal); Process development, analytical method qualification/validation, GMP testing; Phase appropriate quality systems and Quality by Design; CRO audits and management
  • Preferred experience with vaccine development / cell culture platforms in R&D.
  • Understanding of FDA and EU regulatory CMC requirements and GxP requirements (GLP, GCLP, GMP), and the applicability to early development programmes
  • Advanced skills in project management and proven success in leading multiple projects simultaneously
  • Possesses key leadership competencies to include making difficult decisions, relationship-building, influencing, fostering teamwork, and knowledge of the business to exercise sound judgment
  • Highly skilled in influencing peers, and executive management on new approaches and change initatiatives