Quality Compliance Manager

Career Category

Job Description

Join our team at AMGEN Capability Center Portugal, number 1 company in Best Workplaces - https://www.greatplacetowork.pt/ - ranking in
Portugal (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 300 talented people and more than 35
different nationalities, diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to
explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance,
General & Admin, Human Resources, Regulatory Affairs and many more. In Lisbon's city center, our AMGEN office fosters innovation,
excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients. What we do at AMGEN matters in
people’s lives.

QUALITY COMPLIANCE MANAGER

LIVE

WHAT YOU WILL DO

Let’s do this! Let’s change the world! In this vital role, you will report to the Sr Manager of Quality Compliance & Research Quality (CRQ). As the Quality Compliance Manager, you will play a crucial part in our mission, providing proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program.

The R&D Process Quality team supports the Quality Management System (QMS) across all Amgen research areas, including discovery through the clinical development lifecycle. This team ensures that all Amgen’s business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgen’s R&D Business Process Network develops and manages fit-for-purpose standards (SOPs) that are continuously improved upon using quality by design (QbD) and risk management methods, including QMS analytics showing quality signals and trends.

Responsibilities:

• Generate and review process area Knowledge Maps, determine inherent and residual risks, document risk assessments, and collaborate with Business Process Owners and Quality Leads to ensure accurate risk classification and preventive actions.

• Collaborate with GCP Subject Matter Expert, providing independent and objective quality advice supporting business procedures managed by Business Process Owners (BPOs).

• Provides Quality oversight related to continuous improvements (CI) associated with our 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.

• Supports Amgen’s procedural framework so that all procedures maintain compliance with relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity.

• Supports the Business Process Owner network by ensuring risk-based improvements to procedures to ensure that they are simple, efficient, and fit for purpose while maintaining regulatory compliance.

• Supports risk methodologies to selectively audit business processes across the R&D network that will ensure improvements to procedures through robust root cause analysis and CAPA aimed at improving procedures.

• Identify industry best practices for optimal (standardized and lean) procedural documentation and the use of technology to drive an efficient and effective knowledge management system.

• Contributes and supports R & D with the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA).

• Supports a robust regulatory intelligence system by monitoring changing regulations and ensuring that the BPO network incorporates changes efficiently and timely.

WIN

WHAT WE EXPECT OF YOU

We are different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills and has these qualifications.

Basic Qualifications:

• Master’s degree and 2 years of Quality/Compliance/Process Management experience OR

• Bachelor’s degree and 4 years of Quality/Compliance/Process Management experience OR

• Associate’s degree and 8 years of Quality/Compliance/Process Management experience Or

• High school diploma / GED and 10 years of Quality/Compliance/Process Management experience

Preferred Qualifications:

• 7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

• Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes.

• Solid understanding of SOP/Standards management and methods/ technology used to drive knowledge management across a diverse R&D environment.

• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMSs such as Veeva or Trackwise.

• Thorough understanding of Clinical R&D activities and Global Regulations.

• Experience with Regulatory Submission and Inspection Management procedures.

• Strong analytical, critical thinking, and decision-making abilities.

• Strong Process Mind and analytically oriented - experience with process monitoring, including applying analytical methods and modern technology to enable signal detection and quality improvement.

• Proven team player – takes direction and can rapidly learn and support a hard-working team, making rapid decisions and communicating them promptly.

• Excellent verbal and written communication skills - demonstrates strong business writing abilities and active listening.

• Capability to understand and articulate technical concepts and literature in spoken and written English.

THRIVE
WHAT YOU CAN EXPECT OF US

• Vast opportunities to learn, develop, and move up and across our global organization. 

• A diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act. 

• Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits. 

• Flexible work arrangements.

APPLY NOW

Objects in your future are closer than they appear. Join us.  

CAREERS.AMGEN.COM

EQUAL OPPORTUNITY STATEMENT  

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.  

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.