Sr. Specialist, R&D FLQA

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 in R&D QA provides frontline QA oversight of bulk and fill finish manufacturing activities for clinical trial material produced in Holly Springs, NC and related changes and deviations.  Provides support in Holly Springs for assuring quality during GMP clinical manufacturing activities, liaising with site colleagues to align on the preferred approach for proposal to stakeholders. Supports the development and maintenance of quality procedures and systems related to area of expertise.

Provide Quality oversight of R&D activities

• Ensures bulk and semifinished material for clinical batches comply with applicable Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) requirements, current clinical trial protocol registered with the applicable health authority and phase-appropriate cGMP.
• Supports the development of batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, development/validation/qualification protocols and reports etc. to comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.
• Reviews and approves executed batch records and development/validation/qualification protocols
• Ensures data integrity and by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness.
• Coordinates approval of documents to support batch release activities with Clinical Batch Dispo and commercial QA/Qualified Person (QP)
• Authors phase appropriate FLQA procedures for oversight of clinical manufacturing activities
• Provides QA oversight on the shop floor to the manufacture and distribution of products for clinical trials in Holly Springs, including sterile manufacturing and liasing with TD, Operations, QC, sterility assurance etc. as required
• Provides QA oversight to level 0 changes and minor deviations related to clinical trial manufacturing, and owns actions and otherwise supports higher level changes/deviations
• Supports the implementation of the quality strategy for phase-appropriate manufacturing of clinical trial material, which may be either internal or outsourced to Contract Manufacturing Organisations, and identified areas for continuous improvement

Establishes relationships with R&D QA and other global Quality functions:

• Advises R&D on applicable requirements, partnering with more senior members in R&D QA for complex issues
• Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets

Helps maintain the Quality System in R&D

• Identifies and escalates risks to compliance to senior management
• Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities
• Supports internal audits and helps prepare for regulatory inspections
• Supports inspection finding responses related to applicable area of oversight
• Supports the provision of accurate and timely reports on metrics, findings, risks and trends

• Bachelor’s degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred.
• 3+ years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry.
• Previous work in a QC, Research, Development, Manufacturing or Quality role required.
• Experience working across different market areas and different phases of R&D preferred (Product Development/ GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization)
• Requires conceptual and practical expertise in QA oversight of R&D work (non-regulated, GLP and preparation for GMP tech transfer)
• Demonstrated leadership capabilities in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, and problem solving
• Experience in biopharmaceutical development either as a technical expert or providing QA oversight in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification, Drug Product
• Effective delivery of objectives in a complex matrix environment and ability to deal with rapid change
• Effective verbal & written communication skills in a cross functional environment with attention to detail
• Ability to present solutions to complex and strategic issues
• Evidence of commercial awareness in technical strategies
• Excellent customer focus with demonstrated management of customer expectations
• Effective presentation skills