Summary
Overview
Work History
Education
Skills
Personal Information
Timeline
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Bree Ann Crossley
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Bree Ann Crossley

Summary

Strategic Product Quality Strategy Lead with a robust background in quality risk management and regulatory compliance. Facilitates effective product lifecycle strategies through comprehensive risk assessments and governance, underscoring a commitment to delivering high-quality biopharmaceutical products.

Overview

25
25
years of professional experience

Work History

Director, Product Quality Strategy Lead

GlaxoSmithKline (GSK)
05.2022 - Current
  • Serve as matrix Product Quality Strategy Lead for a portfolio of commercial and development assets, driving end-to-end quality strategy and oversight across drug substance, drug product and analytical operations to meet strategic milestones. Key programs include: Xevudy, Nucala, and Exdensur.
  • Shaped product and process strategies by assessing new products, technologies, and manufacturing approaches against global regulatory expectations and internal GSK standards; defined quality requirements, control strategy considerations, and risk-based decision points crucial for moving products through development, launch, and lifecycle management.
  • Partner with development functions and Global Supply Chain (GSC) to design and optimize manufacturing strategies, new product introduction standards and control strategies, ensuring that commercial and lifecycle plans remain compliant and competitive.
  • Led cross-functional risk assessment forums, providing product quality insights on technical, regulatory, and supply risks; evaluated risk severity, defined practical mitigations, and tracked actions through governance routines.
  • Chaired Change Control Panel, conducting cross-functional reviews of product, process, analytical, and supply changes; drove risk-based decisions, confirmed quality and regulatory impacts, and aligned stakeholders on implementation plans.

External Quality Assurance Operations Manager

GlaxoSmithKline (GSK)
03.2021 - 05.2022
  • Functioned as CGT SME for internal audits on CMO oversight and drug product release, directing a global team of QA specialists to align priorities with portfolio needs and strategic launches.
  • Owned end-to-end product release strategy for CGT drug products (Phase IIII), overseeing batch release office activities and ensuring alignment to regulatory submissions and product quality profiles.
  • Directed third-party product supply strategies, including audit and pre-approval inspection readiness, KPI frameworks, and performance reviews, ensuring external manufacturers met product quality and supply objectives.
  • Approved critical GMP documentation (QMS policies, SOPs, master batch records, validation packages, change controls) to uphold coherent, risk-managed product strategies across partners and internal functions.

Process and Systems Manager Cell & Gene Therapy

GlaxoSmithKline (GSK)
04.2020 - 04.2021
  • Developed and approved CGT global QMS policies that facilitated product development, commercialization, and alignment with long-term portfolio strategy.
  • Deployed and maintained the R&D QMS as a platform for product quality, data integrity and Continuous Improvement.
  • Identified and monitored CGT manufacturing and third-party oversight risks to inform product and portfolio decision-making.

Senior Contract Manager Third Party Resourcing

GlaxoSmithKline (GSK)
01.2018 - 03.2020
  • Led Biopharm CMC outsourcing strategies to ensure responsive supply base for CMC, bioanalysis, and analytical testing aligned with portfolio priorities.
  • Coordinated third-party risk reviews across anti-bribery and corruption (ABAC), EHS, data integrity, and information risk, facilitating compliant external resourcing decisions.
  • Drafted and negotiated contracts with suppliers and service providers.
  • Managed contract compliance and identified potential risks in agreements.
  • Collaborated with cross-functional teams to align contract terms with business goals.

Regulatory Compliance Lead Global Supply Chain

GlaxoSmithKline (GSK)
King of Prussia, PA
08.2015 - 01.2018
  • Led regulatory and quality compliance strategy for Nucala drug substance supply, ensuring adherence to US, EU, PMDA, and RoW requirements and supporting effective lifecycle planning.
  • Directed pre-inspection and Pre-PAI readiness activities, reinforcing site systems for Nucala and enhancing compliance across broader product portfolios.
  • Led initiatives to enhance manufacturing regulatory capability, overseeing QMS, change control, and documentation teams to ensure robust compliance.

Regulatory Project Manager CMC Regulatory Affairs

GlaxoSmithKline (GSK)
King of Prussia, PA
02.2013 - 08.2015
  • Prepared and submitted global CMC regulatory applications (BLA/MAA/JNDA, IND/IMP, CTA) for key biologic products, aligning clinical, CMC, and quality strategies from Phase 1 through Phase 3.
  • Represented CMC Regulatory on cross-functional development teams, shaping product development strategy and submission content (characterization, stability, expiry) to ensure timely regulatory submissions across regions.
  • Led regulatory impact assessments for change controls and coordinated responses to health authorities, utilizing RCA and CAPA to enhance product strategies and lifecycle management.

Education

Certificate - QA / Regulatory Affairs

Temple University
Philadelphia, PA
05-2006

Bachelor of Science - Microbiology

University of The Sciences in Philadelphia
Philadelphia, PA
05-2000

Skills

  • Regulatory strategy
  • Quality systems management
  • Product lifecycle management
  • Risk Assessment & Mitigation
  • Third-Party / CMO Product Supply & Quality Oversight
  • Product Release Strategy
  • Quality management
  • Portfolio & Program Governance
  • Operational excellence
  • Cross-functional leadership
  • Global regulatory intelligence

Personal Information

Title: Product Quality Strategy Lead

Timeline

Director, Product Quality Strategy Lead

GlaxoSmithKline (GSK)
05.2022 - Current

External Quality Assurance Operations Manager

GlaxoSmithKline (GSK)
03.2021 - 05.2022

Process and Systems Manager Cell & Gene Therapy

GlaxoSmithKline (GSK)
04.2020 - 04.2021

Senior Contract Manager Third Party Resourcing

GlaxoSmithKline (GSK)
01.2018 - 03.2020

Regulatory Compliance Lead Global Supply Chain

GlaxoSmithKline (GSK)
08.2015 - 01.2018

Regulatory Project Manager CMC Regulatory Affairs

GlaxoSmithKline (GSK)
02.2013 - 08.2015

Certificate - QA / Regulatory Affairs

Temple University

Bachelor of Science - Microbiology

University of The Sciences in Philadelphia
Bree Ann Crossley