Nancy Phan Email & Phone Number

Melbourne, Victoria, Australia

As a part of the evolution of my previous role and organisation, I am responsible for providing quality leadership for CSL Behring Broadmeadows Site Portfolio Projects and Global Quality Engineering team, as well as providing harmonisation as Quality SME across all global CSL Sites.

Melbourne, Victoria, Australia

In this role I am responsible for the quality strategic oversight of expansion projects, and lifecycle management of QbD, Tech Transfer, Validation and Continuous Process Verification processes globally. I have developed and lead a global team of managers located across four manufacturing sites in Australia, Switzerland, Germany and US. Key highlights include:• Establishing a new matrix organisation and team for Quality Engineering. This included creating a structure, recruitment of all global team members, contributing to vision, mission, and objectives, and also sharing with the company our roles, responsibilities and values.• Receiving regulatory approval and successful PEI Inspection for new global KNC Base Fractionation facility in Germany (Project Phoenix): $800 million expansion project. PEI Inspection saw only 4 minor observations relating to site systems. FDA Approval received in 2023. • Being QMS Process Owner for new global SOP for Quality Stage Gate to ensure clearly defined GMP requirements for project phases, and a risk based collaborative approach for transitioning between key milestones. This SOP aligned CSLB, Seqirus and R&D business units. • Leading a team who manages 60+ portfolio projects for the CSL Behring organisation, including new products, new facilities, internal technology transfers, CMO technology transfers and process optimisation.

Broadmeadows, Victoria, Australia

In this role I am responsible for quality deliverables for Site Expansion and Capital Projects. I lead a team who support technology transfer, QbD, design, qualification, analytical, change controls, operational readiness, validation, comparability, stability, regulatory submissions, PAI inspections, project governance, steering committees, schedule and budget reviews. Key highlights include:• QA Lead for 2 COVID-19 Vaccine Candidates (Clinical Trial and Commercial) and 1 COVID-19 Therapeutic product as a part of pandemic response.• QA Lead for Global Base Fractionation facility (Project Aurora): $900 million expansion project. This new facility received TGA regulatory approval in 2022 and FDA approval in 2023.• QA Lead for Privigen Module IV facility: $60 million expansion project delivered 3 months ahead of schedule and in budget to support global supply. • Developing a team who provides quality oversight and direction for capital projects including new facilities, products and process optimisations.• Developing globally endorsed, well balanced change control strategies and methodology for site expansion projects.• Embarking on a Short Term International Assignment in CSL Behring AG, Bern, Switzerland for 3 months in 2017 / 2018.

Broadmeadows, Victoria, Australia

In this role I was responsible for deviation and investigation management, supporting batch release and quality oversight for Bulk and Biotechnology Manufacturing facilities, as well as QC and raw material investigations. I also hosted a number of regulatory inspections, and was a key contributor for successful market approval of our first FDA Approved plant at the Broadmeadows site.

Broadmeadows, Victoria, Australia

In this role I was responsible for global and local supplier qualification program, global supplier audits in Asia Pacific region, global quality agreements, internal audit program, supporting regulatory inspection program and leading site compliance projects.

Mulgrave, Victoria, Australia

In this role I was responsible for the execution and management of a quality transformation project involving the introduction of risk management to the deviation and CAPA eQMS systems. This also included analysis of deviation trends covering Quality Operations, Production, QC, Microbiology and Engineering, as well as roll out of training to the site.

Mulgrave, Victoria, Australia

In this role I was responsible for performing supplier audits for local and global pharmaceutical suppliers including API, contract laboratories, raw materials, excipients, stoppers, caps, glass vials, filters, components, product labels, product leaflets and product cartons. Additional responsibilities including introducing a risk based supplier qualification, performing supplier assessments, quality agreements, TSE / BSE assessment, and coordinating regulatory inspections and customer audits for the quality compliance group.

Parkville, Victoria, Australia

In this role I was responsible for batch release, management of staff, change controls (process and document), OOS, deviations, investigations, CAPA, PQR, internal and external regulatory audits and responses for Antivenom and Q- Fever Injectable product portfolio and supporting Bulk manufacturing, QC, Stability, Filling and Packaging groups.

Parkville, Victoria, Australia

Parkville, Victoria, Australia

CSL Biotherapies

Broadmeadows, Victoria, Australia

Formerly CSL Bioplasma, Haemostasis group at Broadmeadows site.

Masters Of Biotechnology & Business (Mba Exec), Business Administration And Management, General

European Management course completed at Grenoble Ecole de Management, Grenoble France 2011 (MBA exec study tour)

Bachelor Of Science (Biochemistry/ Biotechnology), Biochemistry