Career CategoryQuality
Job DescriptionQuality Compliance Senior Manager What you will doLet's do this. Let's change the world.
- 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.
- 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 with 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 periodic basis to key stakeholders.
- 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.
Key Capabilities- Maintain knowledge of current regulatory and quality practices/issues and provide continuous training and education
- Establish proven track record of GCP expertise and is able to provide advice on complex issues
- Technical knowledge of at least one R&D audit specialty area
- Knowledge of R&D function and business principles
- Applies analytical skills to evaluate and interpret Quality situations/issues using multiple sources of information, including qualitative, quantitative and trend data
- Works under minimal direction and independently determines R&D Quality approach that are thorough, practical and consistent with the R&D Quality TA program
- Manages multiple assignments
- Meets timelines for the reporting of R&D audits and other activities
- Communicate effectively locally, regionally and globally
- In-depth disciplinary knowledge; leverages business acumen and subject matter expertise
- Employs project management techniques
- In-depth understanding of company, regional and country goals
- Provide coaching /mentoring to staff and provide cross training for staff in area of expertise
- Support achievement of departmental goals
Knowledge- Through understanding of Clinical R&D activities and Global Regulations
- Thorough Knowledge and application of international requirements of Good Clinical Practice(GCP) and/or Good Pharmacovigilance Practice (GPV) (required)
- Through knowledge of R&D processes and operations
- Knowledge of the Regulatory Submission and Inspection Management procedures.
- Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:- Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
- Master's degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
- Bachelor's degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
- Associate's degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
- High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
Preferred Qualifications:- Bachelor of Science degree in appropriate discipline
- Advanced degree (e.g., Master's degree or PhD)
- Quality Assurance Qualification/Certification
- Minimum of 7 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
- Minimum of 5 years' experience as an auditor, preferably in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
- Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities
- Leadership or mentoring experience
- Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise.
- 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, critical-thinking, and decision-making abilities.
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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.comSalary Range132,037.30USD -178,638.70 USD
