Director, Product Quality Leader, Biologics

• Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision making, performing a scientifically sound and risk-based evaluation of process and product quality data, and developing patient-oriented strategies.
• Execute/drive product strategies through strong quality and scientific knowledge related to product development, technology transfers, global regulatory filing strategies, analytical methods, stability, drug substance and drug product specifications and In-Process Controls (IPCs).
• Lead Product Quality Team (PQT) activities to align on product quality strategy, priorities, and deliverables across the product lifecycle.
• Through the product quality risk register, drive identification, assessment, and mitigation of product quality risks using a science- and risk-based approach.
• Monitor and review cross-functional process and product data to identify trends and ensure quality and compliance risks are proactively addressed and escalated, as needed.
• Lead the development of control strategies, including in-process control, starting material, drug substance and drug product specifications, stability strategy, and comparability approaches.
• Reviewand approve regulatory filings and support responses to health authority questions.
• Provide cross-functional guidance to align product quality strategy across development, manufacturing, analytical, and regulatory stakeholders.
• Assess product quality impact for changes, deviations, and events, and ensure appropriate implementation plans are developed.
• Support drug substance and drug product technology transfer and new product launches.
• Ensure inspection readiness, including PAI/PLI preparation through participation as a product expert.
• Apply science- and risk-based evaluation to complex issues and develop practical, patient-focused solutions that balance quality, regulatory expectations, and business needs.
• Communicate complex quality and technical information clearly to leadership, cross-functional teams, and regulatory agencies.
• Act as delegate to Commercial Product Quality Head, as needed

Knowledge, Experience and Skills:

• In-depth understanding of cGMP principles and applicable regulatory guidelines and directives (e.g., ICH, EP, JP, USP, 21 CFR).
• Demonstrated experience applying science- and risk-based approaches to product quality, including control strategy, comparability, and lifecycle management.
• Solid knowledge of drug substance and drug product development, manufacturing processes, and associated quality considerations.
• Experience working in cross-functional teams within a matrix environment, with the ability to influence decisions without direct authority.
• Proven ability to lead or contribute to complex product/program activities, including regulatory filings, product quality assessments, and lifecycle management.
• Experience supporting inspections (e.g., PAI/PLI) and interacting with regulatory agencies.
• Strong technical and analytical skills, with the ability to interpret complex product and process data and translate insights into risk-based decisions.
• Ability to identify, assess, and communicate product quality risks and drive appropriate mitigation strategies.
• Effective problem-solving skills, including developing practical, patient-focused solutions to complex quality issues.
• Strong written and verbal communication skills, with the ability to clearly convey complex quality and technical information to cross-functional teams, leadership, and regulatory agencies.
• Ability to operate independently, manage multiple priorities, and make sound decisions in a fast-paced environment.