9 дней назад
Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support
191 250 - 247 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support (GMP facilities, utilities, and equipment): Leading global Quality strategy and technical oversight for regulated infrastructure and assets across a biopharmaceutical network with an accent on lifecycle compliance, risk-based governance, and reliability. Focus on harmonizing quality programs, overseeing commissioning and validation, guiding investigations and CAPA, and supporting regulatory submissions and inspections.
Location: United States - California - Santa Monica
Salary: $191,250–$247,500 per year, with potential annual bonus, stock-based long-term incentives, paid time off, and benefits.
Company
is a biopharmaceutical company developing personalized CAR T-cell and T-cell receptor therapies for cancer treatment.
What you will do
- Define and maintain enterprise quality policies, standards, strategies, and lifecycle controls for GMP facilities, utilities, and equipment.
- Provide independent Quality oversight and approval for infrastructure, assets, new process design, facility start-up, commissioning, qualification, and validation.
- Lead network-wide harmonization, continuous improvement, governance, and reliability initiatives.
- Guide risk-based decisions, significant investigations, corrective and preventive actions, and lessons-learned programs.
- Oversee Quality input for regulatory submissions, inspections, observations, and commitments through closure.
- Partner with Facilities, Engineering, Manufacturing, Quality, suppliers, and senior stakeholders while building organizational capability through mentoring and knowledge programs.
Requirements
- PhD with 8+ years, Master’s degree with 10+ years, Bachelor’s degree with 12+ years, Associate’s degree with 14+ years, or High School diploma with 16+ years of relevant experience.
- Relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment.
- In-depth knowledge of U.S. and international GMP requirements, standards, and best practices for facilities, utilities, and equipment.
- Ability to develop risk-based solutions, analyze reliability data, and communicate complex technical and Quality matters to technical, business, and executive audiences.
- Experience with quality oversight for commissioning, qualification, and validation of facilities, utilities, and equipment.
- Work location: United States, California, Santa Monica.
Nice to have
- Experience leading global, cross-functional facilities, utilities, and equipment quality programs.
- Experience with reliability engineering and risk-based principles for pharmaceutical or similar manufacturing assets.
- Experience with cell and gene therapy manufacturing and related infrastructure requirements.
- Relevant professional certification such as CQE or CQA.
Culture & Benefits
- Mission focused on developing innovative cancer immunotherapies and improving long-term patient outcomes.
- Inclusive environment focused on employee development, empowerment, accountability, and continuous improvement.
- Medical, dental, vision, and life insurance plans.
- Paid time off and potential discretionary annual bonus and stock-based long-term incentives.
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