CrawlJobs Logo

Senior Manager Quality Compliance (Rare Disease)

United States 132037.30 - 178638.70 USD / Year · Job Posted July 03, 2026
Apply Position
Job Link Share

Job Description

Join Amgen’s Mission of Serving Patients. At 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Job Responsibility

  • 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
  • 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

Requirements

  • Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
  • Master’s degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
  • Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
  • Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
  • High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector

Nice to have

  • 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 we offer

  • Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts
  • 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

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Senior Manager Quality Compliance (Rare Disease)

8 matching positions

Global Insights, Senior Manager Rare Disease

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States , Chicago; Thousand Oaks
Salary
Salary:
155747.20 - 210716.80 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of market research, analytics, competitive intelligence, sales and/or marketing operations experience
  • Master’s degree and 6 years of market research, analytics, competitive intelligence, sales and/or marketing operations experience
  • Bachelor’s degree and 8 years of market research, analytics, competitive intelligence, sales and/or marketing operations experience
  • Associate’s degree and 10 years of market research, analytics, competitive intelligence, sales and/or marketing operations experience
  • High school diploma / GED and 12 years of market research, analytics, competitive intelligence, sales and/or marketing operations experience
  • Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Job Responsibility
Job Responsibility
  • Synthesize information from a variety of sources to develop strategic insights that address business needs
  • Integrate insights and knowledge to develop business cases and facilitate workshops to support clinical development plans, lifecycle management and other strategic decisions
  • Plan, design, and lead primary market research with a research agency for assets across various phases of the product lifecycle
  • Lead ad hoc strategic secondary analytics to inform strategic decisions
  • Be the subject matter expert on HCP, patient, and payer insights for the brand
  • Clearly communicate insights and recommendations to variety of audiences, including senior leadership
  • Partner with commercial leadership and cross-functional partners to define and prioritize objectives, budget and work plans
  • Identify, evaluate, and manage relationships with best-in-class vendors
  • Support advancement of AI capabilities for insights generation
  • Support Amgen’s advancement in marketing excellence through aligned insights generation and deep brand-building knowledge
What we offer
What we offer
  • Retirement and Savings Plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Fulltime
Read More
Arrow Right

Senior Director, Patient Marketing (US, Rare Disease)

Alfasigma is a privately held global healthcare company founded over 75 years ag...
Location
Location
United States , Morristown
Salary
Salary:
260000.00 - 310000.00 USD / Year
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree required
  • MBA or advanced degree preferred
  • 15+ years of experience in pharmaceutical/biotech patient or consumer marketing, or related commercial roles
  • Demonstrated experience leading patient marketing strategy in a regulated environment
  • US launch experience strongly preferred
  • Experience in liver, metabolic, or related chronic disease areas preferred
  • Ability to work onsite at the US headquarters office in Morristown, NJ, on a hybrid basis (2-3 days a week)
  • Proven ability to lead cross-functionally, influence without authority, and operate effectively in a launch-focused organization
  • Learning agility and 'scalability' to take on increasing responsibility as Alfasigma grows
  • Consistent demonstration and embodiment of our Corporate Beliefs: Passion for Innovation
Job Responsibility
Job Responsibility
  • Lead development of the US patient marketing strategy for Lynavoy, spanning unbranded disease education and branded engagement
  • Define clear patient value proposition and journey framework across diagnosis, treatment initiation, and ongoing management
  • Ensure strategies that are aligned with HCP marketing strategy and that reflect real world patient needs, barriers, and lived experiences
  • Serve as the Patient Marketing lead for US launch readiness, ensuring all patient programs, materials, and resources are timely developed and backed up by patient research and validation
  • Partner with cross-functional launch teams to integrate patient marketing into overall brand and launch strategy
  • Develop phased plans that evolve from pre-launch education to post-launch onboarding, activation, and adherence support
  • Work with Director, Omnichannel & Digital Marketing, to support development of a compliant, integrated patient engagement ecosystem across digital and non-personal channels
  • Partner closely with Patient Advocacy to embed aligned patient perspectives into strategy, content, and programs and to identify synergies
  • Support patient advisory boards and community engagement initiatives in a transparent and compliant manner
  • Ensure alignment with advocacy partners while maintaining clear boundaries and ethical standards
What we offer
What we offer
  • 401(k) plan with company match
  • Rewards and recognition program
  • Health care benefits (medical, prescription drugs, dental, and vision insurance)
  • Short and long-term disability coverage provided
  • Plan coverage for domestic partners
  • Paid parental leave benefits and adoption assistance
  • Tuition reimbursement assistance
  • A generous Paid Time Off program that includes 20 vacation days, 11 holidays, 4 personal days, and 2 volunteer days per calendar year
  • Numerous well-being and work/life programs
  • Fulltime
Read More
Arrow Right

Senior Clinical Research Associate

Senior Clinical Research Associate, FSP Model, Paris, Hybrid or Home based, Prod...
Location
Location
France , Paris
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree in a relevant field such as life sciences, nursing, or medicine
  • Extensive experience as a Clinical Research Associate (4/5 years independent monitoring or more), with a proven track record of managing complex trials within a CRO or Pharma environment
  • Fluency in French and professional proficiency in English (mandatory for reporting and international stakeholder management)
  • In-depth knowledge of ICH-GCP guidelines
  • Proven ability to manage multiple high-priority sites and projects simultaneously, with superior organizational and problem-solving skills
  • Excellent communication and interpersonal skills, with the ability to influence site compliance and represent a leading global sponsor effectively
  • Ability to travel as required to clinical sites and should possess a valid driver's license
Job Responsibility
Job Responsibility
  • Independently monitor Phase II–IV clinical trials as a senior resource dedicated to a major French pharmaceutical leader, ensuring full compliance with ICH-GCP and specific sponsor SOPs
  • Manage clinical studies in France across multiple complex therapeutic areas including Neurology, Rare Disease, Dermatology and Oncology
  • Lead site qualification, initiation, monitoring, and close-out visits, providing expert oversight and ensuring the highest standards of site performance
  • Ensure protocol compliance, data integrity, and participant safety through rigorous source data verification and proactive site management
  • Build and maintain influential relationships with investigators and site personnel to drive recruitment and facilitate smooth trial operations within this exclusive partnership
  • Perform advanced data review and resolution of complex queries to maintain the highest quality of clinical data within the sponsor’s proprietary systems
  • Contribute to the preparation, review, and optimization of study documentation, including monitoring plans and clinical study reports
  • Oversee study documentation, regulatory submissions, and ethics/IRB approvals to ensure strict adherence to trial timelines
  • Drive study cost efficiency and provide proactive resolution for site-level issues to meet critical milestones for our pharmaceutical partner
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
  • Fulltime
Read More
Arrow Right

Senior Director, Commercial Strategy

The Commercial Strategy Senior Director is part of the Global Portfolio and Medi...
Location
Location
Italy , Milano
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in business, science, engineering
  • Minimum 10 years of experience in pharma/biotech in commercial roles
  • Experience in commercial analytics, forecasting, and market insights
  • Knowledge of specialty care and/or rare diseases
  • Experience advising senior executives and leading cross-functional initiatives
  • Proficiency in business analytics, forecasting tools, and data platforms (e.g., IQVIA, claims data, epidemiological sources)
  • Demonstrated success working in matrixed, global organizations
  • Expertise in primary and secondary market research, competitive intelligence, and forecasting methodologies
  • Entrepreneurial and innovation mindset with a strong commercial acumen
  • Strategic agility and ability to thrive in fast-paced, evolving environments
Job Responsibility
Job Responsibility
  • Define the global Commercial Strategy for strategic brands (≥ €800 total revenues)
  • Lead portfolio and brand planning (including Long Range Plan and budget), revenue forecasting, resource allocation and scenario planning
  • Conduct market assessments and maximize go-to-market of our strategic brands
  • Ensure strong Global-to-Local alignment, facilitating consistent insight sharing, harmonized KPIs, and cross-market learnings
  • Lead Market Research initiatives to generate robust, actionable insights
  • Orchestrate data strategy and governance to ensure data quality, time-to-insight and forecast accuracy
  • Build an integrated Insight Engine (epidemiology, market dynamics, patient journey, promotional mix) to support Senior Leadership Team
  • Establish global processes for Brand Plans, Launch Readiness, KPI setting and governance
  • Ensure continuous improvement of the quality of our brand strategy and operation plans
  • Ensure excellence in launches (pre- and post-launch), access readiness, and compliant promotional content and materials
What we offer
What we offer
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development
Read More
Arrow Right
New

Ai Engineer

We are recruiting an AI Engineer for a direct contract with a company based in t...
Location
Location
Portugal , Porto
Salary
Salary:
Not provided
https://www.precisers.pt Logo
Precise
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2+ years experience working within a software development team as an engineer
  • Comfortable writing and debugging code in Python. You understand the importance of readable code and are eager to learn best practices.
  • Familiarity with frameworks like FastAPI, Flask, or Django, with experience developing and exposing/consuming APIs.
  • Understanding of containerization and exposure to Docker.
  • Comfortable using Git for team collaboration (Gitlab pipelines exposure is a plus).
  • Machine Learning Fundamentals: Foundational knowledge of ML concepts and practical experience (academic or personal projects) deploying a simple model using libraries like scikit-learn, PyTorch, or TensorFlow.
  • Experience manipulating and analyzing data using libraries such as Pandas and NumPy.
  • A strong desire to learn MLOps principles, cloud infrastructure, and deployment practices (Kubernetes exposure is a plus).
  • BSc in Computer Science or a related technical field.
Job Responsibility
Job Responsibility
  • Implementing solutions for building and deploying AI models in production, with a focus on fault tolerance, scalability, maintainability and automation.
  • Leveraging modern LLM’s to include/enhance parsing capabilities for CVs/job adverts for existing supported languages and new additional languages.
  • Collaborating with the team to design, implement and optimise data processing pipelines and evaluation tools.
  • Fulltime
Read More
Arrow Right
New

Branch Manager

Come and join us as a results driven Branch Manager to deliver sales and exceed ...
Location
Location
United Kingdom , Lymington
Salary
Salary:
Not provided
cityplumbing.co.uk Logo
City Plumbing
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A great positive attitude
  • Enjoy customer interaction
  • Management Experience
  • Safe Practices
  • Forward Thinking
  • Tenacity and resilience
  • A pro-active approach to sales, with a strong desire and ability to win and grow new business
  • Experience of customer relationship management and developing a true partnership approach
  • Excellent communication skills
  • Self confident and self motivated, with the ability to work on own initiative or as part of a wider team
Job Responsibility
Job Responsibility
  • Effective management of the team and resource
  • Setting the standard of a sales orientated culture
  • Delivering against sales and customer demands while maximising profitability
  • Maximising margin and net profit
  • Keeping everyone safe
  • Build and maintain relationships with new and existing trade and retail customers
  • Ability to interpret and analyse financial and statistical information
What we offer
What we offer
  • Bonus
  • Discounts, savings and cash back at numerous retailers
  • Life assurance
  • Extended family policy including maternity, paternity, additional annual leave and more
  • Mental Health First Aiders and Employee Assistance Programme, we look out for each other
  • Complete induction and a company that lets you grow and encourages development
  • Financial education and loans
  • Flexible working options
  • A business striving to create an environment of inclusion so everyone can be their true self
  • Fulltime
Read More
Arrow Right
New

Guest Environment Expert

Our jobs aren’t just about giving guests a clean room and a freshly made bed. In...
Location
Location
United States , Poughkeepsie
Salary
Salary:
18.00 USD / Hour
https://www.marriott.com Logo
Marriott Bonvoy
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ensuring a safe work place
  • following company policies and procedures
  • maintaining confidentiality
  • upholding quality standards
  • ensuring professional uniform, personal appearance, and communications
  • ability to stand, sit, or walk for an extended time
  • ability to move, lift, carry, push, pull, and place objects weighing less than or equal to 50 pounds without assistance
Job Responsibility
Job Responsibility
  • Delivering guest requests
  • stocking carts
  • cleaning rooms and public spaces
  • maintaining the appearance and cleanliness of the whole hotel
  • Parttime
Read More
Arrow Right
New

Project Engineer

Our client is seeking a motivated and experienced Project Engineer to join their...
Location
Location
United Kingdom , Dartford
Salary
Salary:
30000.00 GBP / Year
https://www.office-angels.com Logo
Office Angels
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven construction based industry experience, (ideally within Smoke Ventilation/Fire Alarm Systems but not essential)
  • Computer literate with strong reporting and organisational skills
  • Excellent interpersonal and communication skills
  • Ability to multitask and manage cross-disciplinary projects
  • Strong time management and decision-making abilities
  • Professional, presentable, and self-motivated
  • Team-oriented with a commitment to exceeding client and colleague expectations
  • Full UK Driving License required, ideally with your own transport
Job Responsibility
Job Responsibility
  • Assist in the development and delivery of Risk and Method Statements
  • Compile detailed project reports covering quality, progress, and issues
  • Measuring up for install jobs and conducting Coordinate on-site deliveries to ensure smooth logistics
  • Support the accounts team with project-related financials and debt collection
  • Monitor project costs and provide financial updates, including profit/loss analysis
  • Communicate effectively with subcontractors and ensure alignment with project goals
  • Manage resources according to the client's program and track project progress
  • Ensure all documentation and certification is accurate, complete, and submitted on time
What we offer
What we offer
  • 23 days annual leave plus bank holidays, rising to 25 days annual leave at 2 years service
  • Company mobile phone
  • uniform and PPE
  • Life Insurance
  • Private Health Care
  • Pension Scheme
  • Fulltime
Read More
Arrow Right