Principal Specialist, GxP Laboratory QA Compliance

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Feb 27, 2021
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 in CMC and Research QA (CRQA) is responsible for team that provides Quality Assurance oversight of lab-based / small-scale activities performed at the site level by R&D under non-regulated and GLP conditions, as well as development according to Quality by Design principles and preparations for tech transfer into the GMP area, to ensure compliance with GxP and Seqirus proceures and data integrity are maintained. Responsible for the development and maintenance of quality procedures and systems related to area of oversight. Provides strategic and technical expertise for the R&D in all GLP and procedural compliance-related matters.

Major Responsibilities:


Provides quality oversight of R&D activities
  • Ensures as applicable that activities in Technical Development (TD) and as needed in Research are compliant with GLP and and/or procedural requirements in Seqirus and data integrity is maintained 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.
  • Ensures laboratory notebooks are issued and upon completion reviewed and archived, and assistance is provided for archiving of other documents
  • Reviews and approves Technical Protocols, Technical Reports, Risk Assessments, associated documentation, etc. for compliance, completeness and data inregrity.
  • 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.
  • Ensure frontline QA oversight is provided 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 verification checks are performed for any data obtained from area of oversight being provided to regulatory authorities (e.g., approving data included in source documents, 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.
  • May provide direct line management for the day to day activities of a small team of 1-2 QA specialists, managing their performance and development


Serves as a Subject Matter Expert in the quality requirements for product development and GxPs that apply, supporting compliance with all applicable SOPs, regulatory requirements and guidance
  • Serves as the CRQA single point of contact on site-based projects in area of oversight, regularly attending cross-functional project meetings and acting as a leader to coordinate, plan and execute work
  • Advises R&D on applicable requirements as go-to SME
  • 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
  • Monitors upcoming industry and regulatory trends


In collaboration with R&D QA and other global Quality functions:
  • Ensures risks to compliance are escalated to senior management and supports identification of mitigations and backup options with cross-functional colleagues
  • Ensures existing systems to manage documentation, change, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities are leveraged as applicable to area of oversight
  • Provides guidance for changes, deviations, failures to meet acceptance criteria, shipping excursions and CAPAs as well as understanding the specific impact on R&D activities and applicable products, enlisting senior management as appropriate for highly complex issues
  • Supports internal audits, 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

Minimum Qualifications:
  • Bachelor's degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred.
  • 5+ 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) in a QC, Research, Development, Manufacturing or Quality role required.
  • Experience working with CROs/CDMOs preferred
  • 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 in-depth conceptual and practical expertise in QA oversight of R&D work (non-regulated, GLP and preparation for GMP tech transfer)
  • Provides in-depth technical advice on issues within own discipline
  • Applies a working knowledge of related disciplines, such as GMP