Job Summary:
The Product Quality Lead (PQL) supports one or more assigned products/programs and serves as theserve as a product expert providingtechnical, scientificand strategicexpertise and leadership to Product CMC (Chemistry Manufacturing and Controls)/Product Development and Manufacturing(PDM)TeamandProduct QualityTeam (PQT)during clinical development throughcommercialization,,acting as the single point ofcontact forproduct quality. The PQLwill define the product Quality and Compliance strategy for theassignedproductsbyleveragingtheirunderstanding of product development tofacilitate theexecution of the strategies that enable the efficient commercialization ofproducts. ThePQL is responsibleforend-to-endProduct Quality deliverables, including ownership, authoring, and review of GMP and regulatory documentation(including Product Quality sections of filings such as JOS), and management of product quality data such as comparability assessments, Annual Product Quality Reviews (APQRs), and product quality risk assessments. The PQL isresponsible forevaluating and driving overall ProductHealth byproactivelyidentifyingand mitigating productrisksandissues, ensuring continuous improvementthroughoutthe product lifecycle. The role supports cross-functionalProduct Quality initiatives to strengthen compliance,enhanceproductquality,andenablerobustlifecycle management.The PQL also serves as the primary Quality interface for alliance management and due diligence activities, ensuring alignment and effective collaboration with external partners.
Job Functions:
- 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 scientificknowledgerelated toproduct development,technology transfers, global regulatory filing strategies, analytical methods, stability,drug substance and drugproduct specificationsand In-Process Controls (IPCs)
- Lead Product Quality Team (PQT) activities toalign onproductquality 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 toidentifytrends and ensure quality and compliance risks are proactively addressed and escalated, as needed.
- lead thedevelopmentof controlstrategies, includingin-processcontrol, startingmaterial, drug substance and drug productspecifications, stability strategy, and comparability approaches.
- Reviewandapprove regulatoryfilings and support responses to health authority questions.
- Providecross-functional guidance to alignproductquality strategy acrossdevelopment,manufacturing,analytical, andregulatory stakeholders.
- Assess product quality impact for changes, deviations, and events, and ensureappropriateimplementationplans aredeveloped.
- Support drug substance and drug product technology transfer and new product launches.
- Ensure inspection readiness, including PAI/PLI preparationthroughparticipation as aproductexpert
- 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 QualityHead, as needed
Knowledge, Experience and Skills:
- In-depthunderstanding ofcGMP principlesandapplicable 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 toidentify, assess, and communicate product quality risks and driveappropriate mitigationstrategies.
- 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 operateindependently, manage multiple priorities, and make sound decisions in a fast-paced environment.
Basic Qualifications:
- PriorQualityleadership and technicalmanagementexperiencein developmentand/orcommercialprograms.
- 12+years of relevant experience and aBachelor’sdegree in scienceor related fields;or10+ years of relevantexperience and an advanced science degree such as MS, ,Pharm D,PhDDemonstrated experience and knowledge inquality ina highly regulated manufacturing environment.
- Direct experience withregulatoryhealth authority submissions (e.g.IND, NDA, BLA, MAA) and/or inspections.
- Broad experience across several includinganalytical productcharacterizationl,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,verbaland 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 anddemonstrateability to organize,prioritizeand 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 ofBLA/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation, highly desired.
- Experience supporting non-conformance investigations, authoring,reviewingand defending critical product impacting non-conformances
- Ability to work and navigate within an evolving
