Quality Compliance Senior Manager

Company: Initial Therapeutics, Inc.
Location: Washington
Posted on: February 18, 2025

Job Description:

Join Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Quality Compliance Senior Manager, Therapeutic Area QualityWhat you will doIn 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 risk-based quality assurance strategy for the clinical development program. In addition, this role will focus on preparation and management for Regulatory Inspections.Each Senior Manager, Quality Compliance 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, Quality Compliance 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 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

• Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans.
• 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 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) or support outsourced audits.
• 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 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 significant quality information on a periodic basis to key team members.
• 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 execution 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 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.What we expect of youWe 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:Basic Qualifications:
  • Doctorate degree and 2 years of quality experience OR
  • Masters degree and 6 years of quality experience OR
  • Bachelors degree and 8 years of quality experience OR
  • Associates degree and 10 years of quality experience OR
  • High school diploma / GED and 12 years of quality experienceIn 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 of 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.
    • Experience with leading Regulatory Agency inspections including managing pre-inspection requests, storyboarding, Front Room and Back Room management, and responses to inspection findings (root cause analysis, CAPA, etc.).
    • Experience with Inspection planning including timeline management, mock inspections, and interview preparation.
    • Leadership or mentoring experience.
    • Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise.
    • Thorough understanding of Clinical R&D activities and Global Regulations.
    • 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 customer 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.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.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.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
      • A 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 sales-based incentive plan.
      • Stock-based long-term incentives.
      • Award-winning time-off plans.
      • Flexible work models, including remote and hybrid work arrangements, where possible.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.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.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.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.
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Keywords: Initial Therapeutics, Inc., Washington DC , Quality Compliance Senior Manager, Executive , Washington, DC