Senior Manager Quality Compliance (Rare Disease)

Location: United States; corporate headquarters in Thousand Oaks, California, with Washington, D.C. also listed in the posting.

Company

hirify.global is a biotechnology company developing and manufacturing medicines across oncology, inflammation, general medicine, rare disease, and obesity-related conditions.

What you will do

• Serve as a Good Clinical Practice subject matter expert and provide independent quality advice for clinical trial activities.
• Provide quality oversight across clinical development programs and support risk assessment and mitigation for critical data, processes, and patient safety.
• Plan, conduct, and report risk-based GCP audits covering investigator sites, affiliates, service providers, and study-level activities.
• Support regulatory inspections, health-authority responses, root-cause analyses, CAPA plans, audit findings, and deviations.
• Analyze quality indicators and trends, recommend corrective actions, and communicate quality metrics to stakeholders.
• Develop risk-based quality assurance plans and apply innovative oversight methods, including data analytics, AI, and Natural Language Processing.

Requirements

• Doctorate degree plus 2 years, master's degree plus 4 years, bachelor's degree plus 6 years, associate degree plus 10 years, or high school diploma/GED plus 12 years of quality, operations, or regulatory compliance experience in the pharmaceutical or biotech sector.
• Thorough knowledge and application of international Good Clinical Practice and/or Good Pharmacovigilance Practice requirements.
• Experience with clinical R&D activities, quality oversight of clinical trials, regulatory submissions, and inspection management.
• Ability to work independently, manage multiple assignments, apply analytical and project management techniques, and communicate across local, regional, and global stakeholders.
• Experience providing coaching, mentoring, training, or cross-training to staff.

Nice to have

• At least 7 years of biopharmaceutical experience in quality management, quality assurance, or a related area.
• At least 5 years of auditing experience, preferably in GCP, GLP, or GPvP.
• Quality assurance certification, an advanced degree, or a Bachelor of Science degree in a relevant discipline.
• Experience supporting regulatory authority inspections and managing electronic quality systems such as Veeva or TrackWise.
• Leadership or mentoring experience with strong business writing and decision-making skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment focused on serving patients with serious illnesses.
• Health, dental, vision, life, and disability insurance, plus flexible spending accounts.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Discretionary annual bonus program and award-winning time-off plans.
• Flexible work models where applicable, along with career development opportunities.

Hiring process

• No application deadline; applications remain open until a sufficient number of candidates is reached or a candidate is selected.
• Visa sponsorship is not guaranteed.