6 дней назад
Senior Manager, External Partners Oversight (Quality/Regulatory)
124 500 - 236 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, External Partners Oversight (Quality/Regulatory): Leading supplier oversight and compliance evaluations for medical device, clinical materials, and drug development partners with an accent on GxP, international regulatory standards, and quality agreements. Focus on detecting and correcting supplier quality issues, managing cross-functional regulatory projects, and analyzing external partner quality metrics.
Location: North Chicago, Illinois, United States
Salary: $124,500–$236,500 per year
Company
develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Lead supplier oversight activities and evaluate compliance with worldwide regulatory requirements.
- Interpret and apply governmental regulations, guidelines, policies, and procedures.
- Manage the full life cycle of Quality Agreements, including creation, periodic review, and termination.
- Provide R&D expertise in GxP requirements and support resolution of external supplier quality issues.
- Lead or participate in technically complex cross-functional projects and regulatory compliance initiatives.
- Collect, analyze, and report External Partners Quality metrics.
Requirements
- Bachelor’s degree in a technical or scientific field such as Chemistry, Pharmacy, Biology, Microbiology, or Engineering, or equivalent industry experience.
- At least 8 years of experience in Quality Assurance, Regulatory Affairs, pharmaceuticals, medical devices, healthcare, compliance, auditing, or laboratory functions.
- Thorough understanding of international regulatory standards, GxP requirements, and quality management systems.
- Technical background and experience with supplier oversight, study or product design, and device development.
- Strong communication, leadership, interpersonal, organizational, analytical, and decision-making skills.
- Professional accreditation such as ASQ Certified Quality Manager or Certified Quality Auditor is desirable.
Culture & Benefits
- Collaborative environment focused on learning, innovation, and cross-functional leadership.
- Paid vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) and eligibility for long-term incentive programs.
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