Senior Manager, Clinical Quality - Remote US

Job Description

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Remote CONUS AK HI

What you will do

Let’s do this. Let’s change the world. In this vital role you will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ). The Senior Manager, Clinical Quality provides proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy for the clinical development program.

Each Senior Manager, Clinical Quality will support end to end Quality Oversight within one of four Therapeutic Areas (TAs): Oncology; Rare Diseases; General Medicine; Inflammation and Biosimilars. Each Senior Manager, Clinical Quality is responsible for supporting a risk based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will play a vital role by developing deep knowledge of the clinical trials you support and providing oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current standard methodology.

Provide quality oversight for Amgen programs for all stages of products in clinical development.

Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits).

Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans.

Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare, and rights.

Support Monthly meetings with clinical program level leaders to review quality and compliance related risks, including but not limited to: on-going quality issues/deviations, quality trends, program filing timelines, potential inspections, and risks related to other programs.

Support response generation for audit findings and self-reported deviations.

Support the establishment of regional expertise to ensure quality and compliance to local regulations

Conduct New Vendor Qualifications/evaluations In a Risk-based Manner.

Prepare, analyze, and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other quality information on periodic basis to key collaborators.

Support TA-specific oversight of key technologies, including technologies for endpoint data collection and measurement (e.g., biomarker usage and imaging methods).

Support the development of TA-specific Quality Assurance plans that are risk based and efficient. This includes protocol specific audit plans, and the follow through of audits using various methods (e.g., remote, or on-site).

Support Clinical Trial Teams for all quality management activities, including management of quality events (e.g., Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and Inspection Management).

Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-based, data analytics that may demonstrate AI and Natural Language Processing, or other statistically based methods).

Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes for risk management activities.

Auto req ID

419027BR

Minimum Education Required

High School/GED

Job_Category

Pharmaceutical

Additional Qualifications/Responsibilities

Basic Qualifications:

Doctorate degree and 2 years of 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.

Or

Master’s degree and 6 years of 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.

Or

Bachelor’s degree and 8 years of 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.

Or

Associate’s degree and 10 years of 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.

Or

High school diploma / GED and 12 years of 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.

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

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.

Leadership or mentoring experience.

Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.

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

Experience with Regulatory Submission and Inspection Management procedures.

Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.

Excellent verbal and written communication skills, including strong business writing abilities and active listening.

Ability to transform business and collaborator feedback into clear, efficient processes using a straightforward language and format.

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

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

144,252.00 USD - 174,193.00 USD

City*

United States

State*

N/A

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen