Quality Compliance Manager

Amgen

Jan 18, 2025

Applications are closed

Job
Full-time
Junior, Mid & Senior Level

Requirements

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.

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.

FAQs

What is the primary role of the Quality Compliance Manager?

The primary role of the Quality Compliance Manager is to provide proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program.

What qualifications are required for this position?

The basic qualifications include a Master’s degree with 2 years of Quality/Compliance/Process Management experience, a Bachelor’s degree with 4 years of experience, an Associate’s degree with 8 years of experience, or a High school diploma/GED with 10 years of experience.

What are the preferred qualifications for the Quality Compliance Manager role?

Preferred qualifications include 7 or more years of experience in Quality Management or Quality Assurance in the pharmaceutical/biotech industry, direct experience working with standard procedural documentation, a solid understanding of SOP/Standards management, oversight of Quality Management Systems, and strong analytical and communication skills.

What responsibilities does the Quality Compliance Manager have in relation to continuous improvement?

The Quality Compliance Manager is responsible for providing quality oversight related to continuous improvements, supporting the application of process metrics, ensuring compliance with relevant laws and regulations, and contributing to R&D with the QMS continuous improvement cycle.

Is experience in electronic Quality Management Systems required?

Yes, experience managing quality in electronic QMSs such as Veeva or Trackwise is preferred for this role.

What is the work culture like at AMGEN?

AMGEN fosters a diverse and inclusive community where employees are empowered to bring ideas to the table, take risks, and act, supporting a culture that emphasizes innovation, excellence, and inspiration.

Are there opportunities for career development within AMGEN?

Yes, AMGEN provides vast opportunities to learn, develop, and move up and across the global organization.

Do we support hybrid work arrangements?

Yes, we do support flexible work arrangements, including hybrid work options.

Is a background in clinical R&D activities important for this position?

Yes, a thorough understanding of Clinical R&D activities and Global Regulations is preferred for the Quality Compliance Manager role.

Does AMGEN offer equal employment opportunities?

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

Amgen

#WeareBiotech

Science & Healthcare

Industry

10,001+

Employees

1980

Founded Year

Mission & Purpose

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.