GxP Supplier Quality Manager

在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。

职位

The Position

At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision.

We serve our patients through external partnerships because access to quality products is every patient’s right. We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide. We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

Your opportunity

Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select,Implement, Manage and Decommission), including but not limited to: process or method validations,Roche audits, Health Authority inspections, complex investigations, product complaints, andregulatory submissions, as assigned.

Develop, negotiate and maintain Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers, as well as with Partners, Collaborators and External Sponsors as applicable, and ensure compliance with agreements.

Collaborate with GxP suppliers to address any gaps in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regards to quality and timeliness with the supplier; and escalate as appropriate.

As applicable, manage all required quality activities to support Make Assess Release (MAR) ofRoche products including approval of master process documentation, batch documentation review,resolution of investigations, assessment of changes, and monitor and report GxP Supplier qualityperformance.

As applicable, release, reject or quarantine Roche products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Roche requirements, cGMP and the schedule. Support RP and QP Declaration and Certification requirements as applicable.

As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs. Also includes quality oversight for direct material changes, certifications, supplier specifications and internal release specifications, and other documentation.

As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of compliance.

As applicable, manage or lead quality deliverables supporting technical transfers for manufacturing,testing, packaging and product launches at external sites

As applicable, engage in supplier improvement initiatives to solve complex manufacturing or quality problems.

Who you are

Ideally, a B.A. or B.S. degree in life sciences or equivalent.

Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience. Experience with GxP suppliers such as CMO, CLO and direct material suppliers is a plus.

Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals.

Ability to interpret quality standards as they relate to GxP suppliers.

Operational Excellence expertise is a plus.

Highly competent in MS office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.

Ability to communicate clearly and professionally both in writing and verbally.

Fluency in oral and written English is a must. Additional language skills are a plus.

This position may require up to 10% domestic and/or international travel.

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。