GLP and GCLP Compliance Expert - Vaccine (Biotech)

Location: Swiftwater, Pennsylvania, United States; U.S. and Puerto Rico residents only. The role requires approximately 30% international travel.

Salary: $113,250–$163,583 annually

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunology, mRNA innovation, AI-driven research, and smart manufacturing.

What you will do

• Support GLP and GCLP activities across the R&D vaccine portfolio and provide guidance on study design, conduct, reporting, and test-item lifecycle management.
• Develop and implement a GCLP-aligned quality management system for clinical laboratory endpoints.
• Support laboratory selection, qualification, oversight, data integrity, traceability, and regulatory compliance.
• Plan and conduct risk-based audits of CROs, laboratories, and other external partners.
• Oversee CAPA implementation, resolve non-conformances, perform due diligence, and support integration of acquired entities.
• Train stakeholders and collaborate with R&D, Clinical, Regulatory, and Quality teams across geographies and time zones.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
• At least 3 years of GLP/GCLP compliance experience in pharmaceutical or biotech R&D.
• At least 3 years of experience leading audits and managing external partners.
• Strong knowledge of FDA, EMA, OECD, and ICH regulatory frameworks.
• Must be a U.S. or Puerto Rico resident and willing to travel internationally approximately 30%.
• Strong cross-cultural communication, autonomy, strategic thinking, and problem-solving skills.

Nice to have

• Master’s degree or PhD.
• Experience representing an organization in regulatory interactions, industry forums, or external engagements.

Culture & Benefits

• Supportive, future-focused R&D environment centered on vaccines and immunology.
• Opportunities for promotion, lateral career moves, and international development.
• Healthcare, prevention, and wellness benefits.
• At least 14 weeks of gender-neutral parental leave.
• Work at the forefront of AI-driven research, smart manufacturing, and mRNA platforms.