Pharmaceutical/Biologics R&D Quality Lead

Glaukos•Aliso Viejo, CA

2d•$130,300 - $162,900•Onsite

About The Position

The R&D Quality Lead, Pharma/Biologics will play a key role in advancing quality strategy and supporting the successful development of pharmaceutical, biologic, and combination products. This position serves as a trusted quality partner across research, development, regulatory, clinical, and manufacturing functions, helping ensure compliance, product quality, and operational excellence throughout the product lifecycle. The role also serves as the primary Quality liaison for external development and manufacturing partners.

Requirements

Bachelor's degree in a scientific discipline such as Biology, Chemistry, Pharmacy, Engineering, Mathematics, or a related field required.
12+ years of pharmaceutical, biologic, or combination product industry experience, or 8+ years with a Master's degree.
Strong experience in R&D Quality, CMC, GMP compliance, clinical supply, supplier oversight, and regulatory submission support.
Demonstrated experience supporting pharmaceutical and biologic product development programs.
Experience applying GMP and regulatory requirements in development or manufacturing environments.
Knowledge of FDA, EMA, ICH, and global GMP regulations.
Understanding of validation principles for pharmaceutical manufacturing, testing, and equipment systems.
Familiarity with global CMC development and regulatory filing processes.
Strong project management, communication, and stakeholder management skills.
Ability to effectively manage multiple priorities and navigate complex quality and compliance challenges in a fast-paced environment.

Nice To Haves

Master's degree preferred.
Audit experience and supplier quality oversight experience preferred.

Responsibilities

Serve as the GMP and R&D Quality subject matter expert for pharmaceutical, biologic, and combination product development programs.
Provide quality oversight for outsourced development and manufacturing activities, including drug substance, drug product, biologic intermediates, clinical trial materials, analytical development, validation, manufacturing, packaging, labeling, release, and stability programs.
Partner with cross-functional teams to provide quality input into product development plans, technology transfer activities, validation readiness, supplier oversight, and commercialization efforts.
Review and approve development and validation protocols, reports, specifications, analytical methods, batch documentation, release records, and CMC documentation.
Support and maintain phase-appropriate GMP quality systems, including change control, deviations, CAPA, supplier quality management, training, documentation control, and data integrity programs.
Ensure quality documentation complies with company standards, industry regulations, and global regulatory expectations.
Provide quality review and support for regulatory submissions, including investigational applications, marketing applications, annual reports, and regulatory updates.
Participate in audits, inspections, and cross-functional project teams to drive continuous improvement and compliance excellence.
Communicate project progress, risks, and recommendations to leadership and key stakeholders.