Director, Product Quality Lead (PQL), Global Quality

• 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. 

Basic Qualifications: 

• Prior Quality leadership and technical management experience in development and/or commercial programs. 

• 12+ years of relevant experience and a Bachelor’s degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, , Pharm D, PhD Demonstrated experience and knowledge in quality  in a highly regulated manufacturing environment.  

• Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections.  

• Broad experience across several including analytical product characterizationl, process validation, drug development experience, packaging/labeling and understanding of Parenteral, Oral Solid Dosage, and Biologics. 

Preferred Qualifications / Skills: 

• 5+ years working in a regulated environment (either direct GMP or technical support) 

• Excellent interpersonal, verbal and written communication skills, including facilitation and presentation skills, are essential in this collaborative work environment. 

• Communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences. 

• Ability to influence others through persuasive interactions and garner support for novel solutions where applicable. 

• Must be able to work on multiple projects simultaneously and demonstrate ability to organize, prioritize and manage time 

• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities. 

• Experience with authoring or review of BLA/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation, highly desired. 

• Experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances 

• Ability to work and navigate within an evolving