7 дней назад
R&D Supplier Quality Sr Manager
132 037 - 178 638$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
R&D Supplier Quality Sr Manager (GMP/GDP): Providing risk-based quality governance and oversight for R&D suppliers and service providers supporting clinical development with an accent on supplier qualification, regulatory compliance, and cross-functional decision-making. Focus on triaging complex supplier-quality issues, maintaining Quality Agreements and KPIs, and escalating risks affecting patient safety, product quality, and clinical trial timelines.
Location: United States - Remote; willingness to travel up to 15% required.
Annual salary: USD 132,037.30–178,638.70.
Company
is a biotechnology company developing and manufacturing medicines for serious illnesses, including heart disease, rare diseases, inflammatory conditions, and cancer.
What you will do
- Provide risk-based quality governance and oversight for R&D suppliers and clinical service providers across GCP, GLP, GPvP, GMP, and GDP requirements.
- Facilitate a cross-functional R&D and Operations forum for clinical quality issues involving GMP/GDP requirements and unclear ownership.
- Coordinate intake and risk-based triage of complex supplier and quality issues, identifying applicable requirements, risks, subject matter experts, and accountable functions.
- Develop and maintain supplier qualification strategies, Quality Agreements, supplier requirements, quality records, KPIs, and metrics.
- Drive escalation, documentation, and continuous improvement for risks affecting patient safety, product quality, regulatory compliance, or clinical trial timelines.
Requirements
- Doctorate degree and 2 years of relevant experience, or a master's degree and 4 years, bachelor's degree and 6 years, associate's degree and 10 years, or high school diploma/GED and 12 years of Quality Management or relevant experience.
- Experience in supplier quality management or oversight, preferably in clinical supply chain quality or GMP/GDP-regulated services.
- Working knowledge of GCP, GLP, GPvP, GMP, and GDP regulations and practices.
- Strong project management, quality risk management, leadership, negotiation, analytical, communication, and influencing skills.
- Experience working in complex, global, matrixed organizations across multiple functions and time zones.
- Must be based in the United States and willing to travel up to 15%.
Nice to have
- Experience with contract negotiations and supplier relationship building.
- Experience with transactional lean, value stream mapping, and process design improvement.
- Experience using tools and systems that support supplier quality management processes.
Culture & Benefits
- Collaborative, innovative, science-based work environment.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time off and career development opportunities.
Hiring process
- Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
- Visa sponsorship is not guaranteed.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
8 дней назад
Associate Director, GMP Operational Quality (Biologics and Devices)
94 600 - 141 800$
9 дней назад
Quality Specialist (Biologics)
89 200 - 95 400$
10 дней назад
Director, Clinical Quality & Development Operations (Biotechnology)
184 000 - 276 000$
10 дней назад
Supply Operations Quality Senior Associate (Pharmaceuticals)
8 дней назад
Quality Senior Specialist (Pharmaceutical Quality)
8 дней назад
Manager, Quality Assurance (Biotech)
140 000 - 160 000$