What are the responsibilities and job description for the Quality Compliance Senior Manager position at BioSpace?
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Quality Compliance Senior Manager
What you will do
Lets do this! Lets change the world! The Senior Manager leads the Quality Intelligence Center (QuIC) integrated quality oversight operating model and the governed signal-to-action lifecycle through which QuIC-generated signals, trends, dashboard outputs, and emerging quality insights are reviewed, contextualized, triaged, routed, monitored, and closed.
The role leads the QuIC team and establishes business standards, review routines, governance inputs, decision pathways, and cross-functional ways of working required to embed QuIC into R&D Quality oversight.
Key responsibilities
Lead the day-to-day operation of the QuIC function and manage a professional team responsible for portfolio-level quality monitoring.
Own and continuously improve the QuIC operating model, including review cadence, signal triage, documentation expectations, escalation pathways, action tracking, and governance routines.
Establish consistent review cadences and business standards for evaluating dashboard outputs, quality metrics, trends, anomalies, threshold breaches, and other QuIC-generated signals.
Lead the review and prioritization of dashboard outputs, quality metrics, trends, anomalies, and threshold breaches to identify issues requiring further assessment or follow-up.
Translate complex quality information, including deviations, CAPAs, audit and inspection insights, operational metrics, and related evidence, into clear, governance-ready summaries, recommendations, and escalations.
Ensure that significant findings are appropriately documented, escalated, and routed to accountable process owners and cross-functional stakeholders.
Define and propose QuIC business rules, operating standards, documentation expectations, escalation pathways, and workflow requirements; ensure changes requiring controlled approval are reviewed through the appropriate accountable Quality governance.
Partner with R&D Quality, Global Development Operations, and other stakeholders to ensure QuIC insights are understood and acted upon.
Lead process improvements and provide business leadership for QuIC enhancements, including signal definitions, thresholds, business rules, data-quality expectations, training, and adoption activities.
Monitor the effectiveness, timeliness, quality, and capacity of oversight activities and implement practical improvements where needed.
Ensure activities comply with applicable GxP, quality-system, data-governance, and internal procedural requirements.
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 experience OR
Masters degree and 4 years of Quality experience OR
Bachelors degree and 6 years of Quality experience OR
Associates degree and 10 years of Quality experience OR
High school diploma / GED and 12 years of Quality experience
Preferred Qualifications
Bachelors degree in scientific, clinical, quality, data, or related discipline, with substantial relevant experience in R&D Quality, clinical development, clinical operations, quality systems, risk management, or centralized monitoring.
Demonstrated experience leading and developing professional employees or leading complex cross-functional teams.
Strong experience interpreting quality, operational, or risk data and converting findings into clear recommendations, escalations, and follow-up actions.
Working knowledge of GCP, quality-risk management, issue management, CAPA and deviation processes, audit and inspection readiness, and quality governance.
Strong communication, stakeholder-management, organizational, and decision-making skills.
Experience as an R&D Quality process owner or in quality oversight across deviations, CAPAs, audits, inspections, management review, or risk-management processes.
Experience with QMS platforms, dashboards, data visualization, data quality, business analysis, user acceptance testing, or digital-product implementation.
Experience with risk-based quality management, centralized monitoring, KRIs, QTLs, CSM, or signal-based quality oversight.
Experience working with AI-enabled analytics or digital quality products, including the ability to critically evaluate system-generated insights and apply appropriate human judgment.
Experience leading operational change in a global matrix environment.
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.
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.com
In 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.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Quality Compliance Senior Manager
What you will do
Lets do this! Lets change the world! The Senior Manager leads the Quality Intelligence Center (QuIC) integrated quality oversight operating model and the governed signal-to-action lifecycle through which QuIC-generated signals, trends, dashboard outputs, and emerging quality insights are reviewed, contextualized, triaged, routed, monitored, and closed.
The role leads the QuIC team and establishes business standards, review routines, governance inputs, decision pathways, and cross-functional ways of working required to embed QuIC into R&D Quality oversight.
Key responsibilities
Lead the day-to-day operation of the QuIC function and manage a professional team responsible for portfolio-level quality monitoring.
Own and continuously improve the QuIC operating model, including review cadence, signal triage, documentation expectations, escalation pathways, action tracking, and governance routines.
Establish consistent review cadences and business standards for evaluating dashboard outputs, quality metrics, trends, anomalies, threshold breaches, and other QuIC-generated signals.
Lead the review and prioritization of dashboard outputs, quality metrics, trends, anomalies, and threshold breaches to identify issues requiring further assessment or follow-up.
Translate complex quality information, including deviations, CAPAs, audit and inspection insights, operational metrics, and related evidence, into clear, governance-ready summaries, recommendations, and escalations.
Ensure that significant findings are appropriately documented, escalated, and routed to accountable process owners and cross-functional stakeholders.
Define and propose QuIC business rules, operating standards, documentation expectations, escalation pathways, and workflow requirements; ensure changes requiring controlled approval are reviewed through the appropriate accountable Quality governance.
Partner with R&D Quality, Global Development Operations, and other stakeholders to ensure QuIC insights are understood and acted upon.
Lead process improvements and provide business leadership for QuIC enhancements, including signal definitions, thresholds, business rules, data-quality expectations, training, and adoption activities.
Monitor the effectiveness, timeliness, quality, and capacity of oversight activities and implement practical improvements where needed.
Ensure activities comply with applicable GxP, quality-system, data-governance, and internal procedural requirements.
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 experience OR
Masters degree and 4 years of Quality experience OR
Bachelors degree and 6 years of Quality experience OR
Associates degree and 10 years of Quality experience OR
High school diploma / GED and 12 years of Quality experience
Preferred Qualifications
Bachelors degree in scientific, clinical, quality, data, or related discipline, with substantial relevant experience in R&D Quality, clinical development, clinical operations, quality systems, risk management, or centralized monitoring.
Demonstrated experience leading and developing professional employees or leading complex cross-functional teams.
Strong experience interpreting quality, operational, or risk data and converting findings into clear recommendations, escalations, and follow-up actions.
Working knowledge of GCP, quality-risk management, issue management, CAPA and deviation processes, audit and inspection readiness, and quality governance.
Strong communication, stakeholder-management, organizational, and decision-making skills.
Experience as an R&D Quality process owner or in quality oversight across deviations, CAPAs, audits, inspections, management review, or risk-management processes.
Experience with QMS platforms, dashboards, data visualization, data quality, business analysis, user acceptance testing, or digital-product implementation.
Experience with risk-based quality management, centralized monitoring, KRIs, QTLs, CSM, or signal-based quality oversight.
Experience working with AI-enabled analytics or digital quality products, including the ability to critically evaluate system-generated insights and apply appropriate human judgment.
Experience leading operational change in a global matrix environment.
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.
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.com
In 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.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.