Senior Manager Quality Compliance (Rare Disease)

Quality Compliance Senior Manager Employs project management techniques. What You Will Do Serve as aGCP Subject Matter Expert, providingindependent and objective quality advice in support of clinical trial activities and in line with current bestpractice. Provide quality oversight for Amgenprogramsfor all stages of products in clinical development. Plan, conduct andreport outon risk-based GCP audits (investigator site audits, affiliate audits,service provideraudits,and study level audits)or support outsourced audits. Manage/support regulatory inspectionsandprovide 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 toensure theproper identification, prioritization,and mitigation ofrisks tocritical data and processesand patient safety, welfare,and rights. Supportmonthly meetings withclinicalprogram levelleadersto reviewquality and compliance related risks, includingbut not limitedto: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 regionalexpertiseto ensure quality and compliancewithlocal regulations. Conductnewvendorqualifications/evaluations in a risk-based manner. Prepare, analyze,and Identify data quality indicators/trends,identifyareas of weakness/gaps,recommend and implement corrective actions and communicate quality metricsand other significant quality information on periodic basis to key stakeholders. Support TA-specificoversight of key technologies,includingtechnologies forendpointdata collection and measurement (e.g.,biomarker usage and imagingmethods). Support the development of TA-specific Quality Assurance plans that arerisk basedandefficient. This includesprotocolspecific auditplans, and the execution of auditsusing various methods (e.g., remote, or on-site). Support Clinical Trial Teams for all quality management activities, includingmanagement of quality events (e.g.,Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and InspectionManagement). Activelyseekand implement innovative and proactive quality oversight methodologies (e.g., risk-based, data analytics that mayleverageAIand Natural Language Processing,or other statistically based methods). Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processesfor 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 andis able toprovide 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 minimaldirection and independently determines R&D Qualityapproachthat are thorough, practical and consistent with the R&D Quality TA program Manages multiple assignments Metestimes 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 ofR&Dprocessesand 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 You We 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 Masters degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR Bachelors degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR Associates 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., Masters 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. Stronganalytical, critical-thinking, and decision-making abilities. What You Can Expect Of Us As 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, well support your journey every step of the way. Benefits 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. Equal Opportunity 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. #J-18808-Ljbffr BioSpace