Principal Product Quality Leader (Biologics)

Location: Remote within the United States, Ireland, or Puerto Rico, subject to applicable work-location requirements

Salary: $138,639–$187,571 USD annual base salary

Company

hirify.global provides AI-powered candidate matching and routes applications to partner companies for review and hiring.

What you will do

• Lead Product Quality activities for late-stage and commercial biologics programs across development, manufacturing, regulatory, and patient-safety priorities.
• Develop and manage science- and risk-based quality strategies, product-quality assessments, and lifecycle plans.
• Lead annual product reviews, stability programs, comparability assessments, specifications, site transfers, and analytical method transfers.
• Author and review GMP and regulatory documentation, including product-quality sections of submissions and responses to regulatory questions.
• Evaluate complex process and product-quality data, support investigations and change controls, and develop practical solutions.
• Partner with Quality Control, Regulatory, Process Development, Quality Assurance, Manufacturing, International Distribution Quality, and senior stakeholders.

Requirements

• Doctorate with 2+ years, Master's degree with 4+ years, Bachelor's degree with 6+ years, Associate's degree with 10+ years, or high school diploma/GED with 12+ years of relevant experience.
• Degree preferably in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 6+ years of experience in a regulated environment, including direct GMP or technical-support experience with biologic products.
• Experience authoring or reviewing market applications, INDs, supplements, or comparable regulatory submissions.
• Strong knowledge of cGMP requirements, international regulatory expectations, scientific data management, documentation, and analytical methods.
• Remote work is available only from the United States, Ireland, or Puerto Rico, subject to applicable work-location requirements.

Nice to have

• Increasing responsibility across quality, analytical development, process development, pharmaceutics, regulatory, manufacturing, or related pharmaceutical functions.
• Experience supporting global, geographically distributed, and virtual teams.

Culture & Benefits

• Comprehensive health and welfare benefits, including medical, dental, and vision coverage.
• Retirement and savings plans with employer contributions, plus life and disability insurance.
• Flexible spending accounts, paid time off, discretionary annual bonus eligibility, and stock-based long-term incentives subject to eligibility.
• Professional development and career growth in a collaborative, science-based environment.
• Exposure to innovative biologics programs and emerging technologies supporting medicines for patients with serious illnesses.
• Inclusive workplace focused on collaboration, scientific excellence, diverse perspectives, and continuous innovation.

Hiring process

• hirify.global uses an AI-powered matching process to evaluate applications against the role's core requirements.
• Shortlisted candidates are shared with the hiring company, which manages interviews, assessments, and subsequent steps.