Director of Quality Assurance and Compliance Specialist

2 semanas atrás


Portugal Amgen Inc. (Ir) Tempo inteiro

About Amgen
At Amgen, our mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines. With a focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year.

Job Summary
We are seeking a Senior Manager, Quality & Compliance to provide proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program. This role will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ).

Key Responsibilities
* Create and maintain data tools to enable stakeholders to ensure quality in the R&D space.
* Maintain Quality oversight related to continuous improvements (CI) associated with our Quality Management System (QMS) through metrics and key performance indicators (KPIs).
* Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews (periodic review by management to ensure QMS health is maintained).
* Ensures our CI efforts maintain a quality culture throughout the R & D and GDO organizations.

Salary Information
This full-time position offers a competitive salary range of $120,000 - $180,000 per year, commensurate with experience. Additionally, Amgen offers a comprehensive benefits package including medical, dental, and vision insurance, 401(k) matching, and paid time off.

Requirements
* Bachelor's degree in a relevant field such as Life Sciences, Engineering, or Business Administration.
* Minimum of 8 years of experience in Quality Assurance, Regulatory Affairs, or a related field.
* Proven track record of developing and implementing quality strategies that drive business results.
* Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.



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