Quality Compliance Senior Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

At Amgen every challenge is an opportunity. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achievetogetherresearchingmanufacturing and delivering everbetter products that read over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

QUALITY COMPLIANCE Senior Manager

LIVE

WHAT YOU WILL DO

Lets do this. Lets change the world. In this vital role you will report to the Therapeutic Area Quality Lead Clinical & Research Quality (CRQ). The Senior Manager Clinical Quality provides proactive end to end quality support for the development and implementation of a riskbased 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 riskbased 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 provide 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 best practice.
• Provide quality oversight for Amgen programmes for all stages of products in clinical development.
• Plan conduct and report out on riskbased GCP audits (investigator site audits affiliate audits service provider audits and study level audits) or support outsourced 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: ongoing quality issues/deviations quality trends program filing timelines potential inspections and risks related to other programs.
• Support response generation for audit findings and selfreported deviations.
• Support the establishment of regional expertise to ensure quality and compliance to local regulations.
• Conduct new vendor qualifications/evaluations in a riskbased 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 significant quality information on periodic basis to key stakeholders.
• Support TAspecific oversight of key technologies including technologies for endpoint data collection and measurement (e.g. biomarker usage and imaging methods).
• Support the development of TAspecific Quality Assurance plans that are risk based and efficient. This includes protocol specific audit plans and the execution of audits using various methods (e.g. remote or onsite).
• 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. riskbased data analytics that may leverage 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.

Country/ Regional Quality Representative

• Manages the framework of analytical tools and data quality indicators/trends across therapeutic areas so that quality is managed at the site and regional level to address areas of weakness/gaps recommend and implement targeted corrective actions
• Provides quality oversight primarily for key target sites in collaboration with operations roles within regions and countries
• Communicates learnings to drive compliance and share best practice through key stakeholders (Development Operations Manager) DOMs Clinical Trial Oversight Manager (CTOMs) etc.
• Provides independent objective quality consultation to the business in support of clinical trials and escalates as needed Serious Breach Committee (SBC) Clinical Trial Committee (CTCC) etc. within regions and countries
• Provides support for local vendor assessments
• Prepares analyzes and communicates compliance metrics and other significant compliance information on periodic basis to key stakeholders at regional and country level
• Maintains knowledge of current regulatory and quality practices/issues and provide continuous training and education
• Manages preinspection/mock inspection visits to sites/affiliates
• Manages regional risk assessments for audit target identification

WIN

WHAT WE EXPECT OF YOU

We are all 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:

• 7 years or more experience in Quality Management Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where riskbased 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 stakeholder feedback into clear efficient processes using a straightforward language and format.
• Strong analytical criticalthinking and decisionmaking abilities.
• Capability to understand and articulate technical concepts and literature in spoken and written English.

Thrive

What you can expect of us

As we work to develop treatments that take care of others we also work to care for our teammates professional and personal growth and wellbeing.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities including:

• Comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts.

• A discretionary annual bonus program or for field sales representatives a salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans and biannual companywide shutdowns

• Flexible work models including remote work arrangements where possible

• Vast opportunity to learn develop and move up and across our global organization

• Diverse and inclusive community of belonging where colleagues are empowered to bring ideas to the table and take risks to act

Apply now

for a career that defies imagination

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

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.