R&D QA Systems Lead (Principal Specialist)

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:

Provides strategic support to global Research and Development (R&D) quality systems, procedures and operational activities which includes, but is not limited to, application of Global Quality Policies & Standards, Change Controls, Deviations, Corrective and Preventative Actions, Vendor Management and managing the reporting of R&D QA metrics and KPIs. This role will directly partner with key stakeholders in R&D, including Research, Technical Development, Clinical Development, Pharmacovigilance and Risk Management, Regulatory Affairs, as well as Medical Affairs, manufacturing sites and other global Quality functions to assure compliance of Seqirus R&D programs to phase-appropriate GxPs, global legal/regulatory requirements and applicable Seqirus Quality Policies.

Major Accountabilities:

Manages the Change Control process with R&D and R&D QA

• Provide training and ongoing support to users to ensure consistent application of standards and principles
• Provide guidance to R&D functional representatives, act as Change Coordinator and/or Approver, through the change control lifecycle
• Ensure appropriate procedural and instructional documents are in place to support effective and compliant use of the system and process
• Coordinate routine R&D Change Panel meetings, and act as Secretariat
• Liaise as required with global Quality and site representatives as applicable

Manages the CAPAs stemming from audits, inspections, deviations and other Quality related assessments, as well as actions stemming from Change Controls

• Provide oversight of execution of CAPA commitments by working closely with CAPA Owners on the implementation and verification of CAPAs and to ensure timely closure of CAPAs
• Manage CAPA tracking within the relevant system and ensure timely issuance of CAPA status reports
• Collaborate with relevant functions in R&D, R&D QA and Site QA to present metrics and trends on Deviations, Change Controls, and CAPAs including effectiveness checks and identification of areas for improvements.

Supports the qualification process and ongoing management of vendors across R&D

• Issue, track and approve quality questionnaires, vendor quality audit responses and related CAPAs and Quality Agreements
• Maintenance of the qualified vendor list
• Perform vendor risk assessments, including tracking of relevant KPIs and quality issues related to vendors
• Development of Quality Agreements and/or Quality Plans
• Serve as QA single point of contact for key vendors as directed by Head, R&D QA Systems, including support of relevant governance forums as required
• Maintain vendor approval documentation and ensure the electronic system of record is kept up to date

Provides oversight of Key Quality Indicators (KQIs) and trends in R&D QA activities including audit results, deviations, Change Control, and CAPA management

• Manages R&D QA metrics related to audits, inspections, deviations, change controls and other Quality related systems; including the tracking and closure of events within the applicable systems
• Develops reports on quality metrics to support the R&D QA functions
• Responsible for analysis of data and identification of trends and needed areas for improvements
• Supports and leads R&D Systems QA governance forums as directed (e.g., Change Control Review Board, Deviation Review Board)

Represent Seqirus R&D QA in global Quality forums and activities

• As directed, represent R&D QA in the review and application of new Seqirus Global Policies, standards / guidances, or SOPs, for all R&D and R&D QA functions
• Initiate, own, or represent R&D QA for relevant change controls, deviations and CAPAs
• Maintain global audit plan in collaboration with all R&D QA functions
• Participates as the QA representative on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams
• Coordinate and facilitate self-inspections and follow-up activities of the Holly Springs operational areas

Supports Health Authority inspections/audits

• Supports Health Authority inspections and audits from a Systems (e.g., vendor management and CAPA management, management review metrics) standpoint, as needed; providing reports and data to assist as required
• Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site
• Ensures that all aspects of quality systems comply with the requirements of the Seqirus Quality manual and meets all relevant GxP regulatory requirements

Innovation

• Refine the established tools related to R&D QA Systems (i.e. auditing, vendor management and CAPA management) and pioneer improvements, as required
• Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing management and usage of each quality system of responsibility
• Interface with other Seqirus and CSL Quality functions to share best practices and identify / leverage opportunities across Quality systems and processes
• Supports special projects as directed

Minimum Requirements:

• Bachelor's degree in scientific discipline/Life Sciences preferred or equivalent experience in biotech or pharmaceutical industry.
• Minimum of 5 years' experience in a GxP regulated environment within the industry, or equivalent, with 3+ years of demonstrated experience with the development, maintenance, training and oversight of Quality Systems required
• Strong knowledge of Quality Systems and change control processes
• Experience in Change Control, Deviation and CAPA management processes
• Experience of collating and reporting of KPI and Metric data is preferred.
• Strong knowledge of EU, FDA and cGMP regulations.
• Excellent interpersonal effectiveness and written/verbal communication skills
• Prior experience of GxP regulations and knowledge of international and national regulations and guidelines related to the conduct of clinical research
• Experience of working with vendors and managing of Quality Agreements