Principal Product Quality Leader (Synthetics)

Location: US - California - Thousand Oaks; preferred onsite, with remote work considered if applicable.

Salary: $138,639.25-$187,570.75 annually.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, rare disease, and other therapeutic areas.

What you will do

• Provide technical expertise and cross-functional product quality leadership for late-phase and commercial synthetic programs.
• Support product quality, annual product review, specification, comparability, stability, site transfer, and analytical method transfer activities.
• Own, author, and review GMP and regulatory documents, filing sections, responses to questions, and product quality impact statements.
• Execute quality system transactions, including change controls and data system activities, while managing product quality data.
• Evaluate complex process and product quality data using science- and risk-based approaches.
• Collaborate with Product Quality, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and other functions on investigations and issue resolution.

Requirements

• Doctorate degree plus 2 years, master’s degree plus 4 years, bachelor’s degree plus 6 years, associate’s degree plus 10 years, or high school diploma/GED plus 12 years of relevant Quality, Operations, Scientific, or Manufacturing experience.
• Experience in a regulated environment, including direct GMP or technical support; 6+ years is preferred.
• Background in chemistry, biochemistry, biology, pharmaceutical sciences, quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing.
• Knowledge of synthetic pharmaceutical bulk and drug product development, manufacturing, analytical techniques, cGMP, and US and international filing regulations.
• Experience with regulatory documentation, non-conformance investigations, project management, and cross-functional work in a matrix environment.
• Strong written and verbal communication, facilitation, and presentation skills.

Nice to have

• Experience with synthetic modalities and technologies such as peptides, siRNA, extended-release formulations, or combination products.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time off plans and career development opportunities.
• Sponsorship is not guaranteed for this role.