Director, Clinical Quality Assurance

Location: Remote/Home-Based, Philadelphia, Pennsylvania; for US-based candidates only

Base salary: $184,000–$276,000 per year, plus potential bonus, equity, and benefits.

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a focus on oncology, neuroscience, sleep disorders, and epilepsy.

What you will do

• Lead strategic objectives and programs for the Clinical Quality Assurance team in alignment with the global quality strategy.
• Provide strategic and technical GCP compliance support to therapeutic area and clinical study teams.
• Oversee CRO and vendor compliance, including quality issue management and performance oversight.
• Identify clinical trial risks, implement mitigations, resolve issues, and drive process improvements.
• Lead regulatory inspection readiness activities and support inspections as required.
• Complete or delegate for-cause audits and investigations while promoting quality and operational excellence.

Requirements

• 14+ years of relevant experience in the pharmaceutical or biotechnology industry.
• Established clinical quality professional with demonstrable CQA compliance experience and thorough knowledge of GCP and applicable regulations.
• Strong knowledge of audit principles, procedures, and techniques.
• Deep understanding of risk management in clinical trials and the ability to apply risk-based approaches.
• Bachelor’s degree in science or a related discipline; a Master’s or PhD is preferred.
• Experience with office IT packages, including eQMS and eTMF, along with strong communication, organization, prioritization, and attention-to-detail skills.

Culture & Benefits

• Remote/home-based work arrangement for US-based candidates.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan.
• Flexible paid vacation.
• Potential eligibility for annual cash bonus or incentive compensation and discretionary equity grants.