Associate Director, QA (Clinical Auditing)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: United States hub locations only — North Chicago, IL; Cambridge, MA; Worcester, MA; Florham Park, NJ; Irvine, CA; or San Francisco, CA. The role includes domestic and international travel and may support GCP inspections onsite or remotely.
Base salary: USD 141,500–268,500 annually, depending on factors including geographic location and experience.
Company
develops medicines and solutions for serious health issues across areas including immunology, oncology, neuroscience, and aesthetics.
What you will do
- Lead and develop a team of Clinical Auditors across the Americas.
- Contribute to global Clinical Audit strategy and drive its implementation across the Americas.
- Lead risk-based clinical audits, execute complex audits, and resolve identified non-compliance.
- Develop quality strategies and improve clinical quality systems in collaboration with business and GxP RDQA partners.
- Analyze clinical development processes to ensure regulatory and corporate compliance.
- Provide expert guidance on clinical regulations and support GCP inspections.
Requirements
- Bachelor’s degree in science, healthcare, nursing, pharmacy, or equivalent experience.
- 7+ years of pharmaceutical industry experience in clinical development, clinical trials regulatory affairs, quality assurance, or a regulatory authority.
- Detailed knowledge of quality systems, auditing standards, quality management principles, ICH, ISO, and worldwide clinical regulatory requirements.
- Strong communication, negotiation, influencing, analytical, and risk-management skills.
- Experience leading cross-functional and multi-location teams through complex projects.
- Ability to think strategically, communicate with senior management, and lead teams effectively.
Culture & Benefits
- Paid time off, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) benefits for eligible employees.
- Eligibility to participate in long-term incentive programs.
- Opportunities to promote continuous education on quality and clinical regulations.
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