GxP Laboratory QA Compliance Lead (Sr. Principal Specialist)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Dec 31, 2020
Ref
R-126446
Required Education
Bachelors Degree
Position Type
Full time
About CSL

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 Quality Assurance oversight of all lab-based / small-scale activities performed (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 and clinical trial sample distribution and testing, to ensure compliance and data integrity are maintained.

Major Responsibilities:

  • 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 and distribution and testing of clinical samples, across all R&D programs globally and internal/external activities
  • Ensures as applicable that activities in R&D are compliant with GLP and GCLP and meet data integrity requirements on an ongoing basis.
  • Reviews and approves SOPs, Work Instructions and other procedures for R&D activities within area of oversight, ensuring compliance with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.
  • Reviews and approves Laboratory Notebooks, Technical Protocols, Technical Reports, Risk Assessments, associated documentation, etc. for compliance and completeness.
  • Partners with TD in the provision of data required for GLP nonclinical batch release and clinical batch release to the Release Responsible Person (RRP) or Qualified Person (QP) as required.
  • Provides 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.
  • Ensures 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)
  • Partners with TD in the technical assessment of whether material suppliers, CROs, Contract Development and Manufacturing Organizations (CDMOs) are fit for purpose for technical work as required.
  • Performs or otherwise arranges audits to support qualification and monitoring of Contract Research Organizations (CROs) performing GLP nonclinical studies and distribution and testing of clinical samples, coordinating with R&D QA Systems to establish Quality Agreements, complete change control, etc.
  • Develops, implements and continuously improves the quality strategy for phase-appropriate manufacturing and release of toxicology and clinical trial material, which may be either internal or outsourced to Contract Manufacturing Organisations
  • Serves as a go-to Subject Matter Expert in the quality requirements for product development and GxPs that apply, supporting compliance with all applicable SOPs, regulatory requirements and guidance
  • Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Good Clinical Laboratory Practice) as well as upcoming industry trends, to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D and applicable sites for relevant markets
  • Ensures new product development work follows a Quality by Design approach (ICH Q8) and is in accordance with requirements of Seqirus Quality policies and SOPs. Reviews and approves key aspects of the Quality by Design approach to establish a control strategy for new products under development (e.g., Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameters, Critical Material Attributes and other aspects of Quality Risk Management)
  • Ensures data integrity is maintained across R&D lab-based / small-scale activities (internal and external)
  • Supports the development, implementation and continuous improvement of the phase-appropriate R&D quality management system, as well as assesses impact of new/updated regulations
  • In collaboration with R&D QA and other global Quality functions, e nsures 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 and distribution and testing of clinical samples
  • 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
  • Supports internal audits and self inspections to ensure R&D quality systems are operated in accordance with established SOPs and GxPs, helps prepare for regulatory inspections and serves as subject matter expert for applicable area of oversight
  • Supports inspection finding responses related to applicable area of oversight
  • Supports 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.

Minimum Qualifications:

  • Bachelor's degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred.
  • 7+ years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry.
  • Previous work in a laboratory (in vitro and/or animal studies) required.
  • Previous work in the pharmaceutical industry, in a QC, Development or Quality role required.
  • Experience managing CROs preferred
  • Experience working across different phases of R&D preferred (Product Development/GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization)
  • Experience applying data integrity, GLP and GCLP principles in different market areas (e.g., US and EU) preferred