BioSpace
Overview
R&D Quality Senior Manager — In this vital role the R&D Quality Senior Manager will play a crucial part in ensuring our organization\'s compliance with regulatory standards and preparing and coordinating a cross-functional team for Regulatory Health Authority inspections globally. The role also involves developing inspection management plans for each identified Regulatory Health Authority inspection, managing the R&D inspection framework, and ensuring appropriate inspection resourcing and alignment across time zones. Additionally, the individual will support Regulatory Inspection Intelligence processes and contribute to operational quality initiatives. The Clinical Quality Inspection team is a diverse international team within the Global R&D Quality organization and is responsible for strengthening and enhancing the R&D Quality Inspection Management System, providing Quality oversight on R&D processes, and leading activities related to GCP regulatory inspections.
Responsibilities
Ensures, that because of inspection preparation activities, story boards are developed for key processes and activities and organizes presentations of the story boards and mock interviews in preparation of potential Sponsor inspections.
Ensures that a cross-functional team (e.g. Quality, Clinical Operations, other functional areas, PV/GPS, GRAAS, DTI, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management to provide real-time, proactive advice and guidance.
Raises potentially significant inspection findings/compliance risks/impact to Senior Management.
Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
Manage the R&D inspection Framework (Calendars, Distribution Lists, Inspection notifications, SharePoint Sites, Training Content, etc).
Liaise with R&D Quality TA Leads to develop appropriate inspection resourcing/scaling and facilities across time zones, and align TA compliance risk identified contact (CT-RACT, specific risk management items e.g. imaging approaches).
Support Regulatory Inspection Intelligence processes and provide input into Operational Quality Initiatives.
What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:
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
Degree Educated
Extensive experience in inspection management within the pharmaceutical or biotechnology industry
Strong knowledge of global regulatory requirements and inspection processes
Excellent communication and presentation skills
Proven ability to work effectively in a cross-functional team environment
Strong organizational and project management skills
Experience with SharePoint and other inspection management tools
Ability to provide proactive advice and guidance on inspection management
Strong problem-solving skills and the ability to raise issues effectively
Ability to travel domestically and/or internationally, depending on business needs, to attend inspections as needed
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, 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, comprising 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. This 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 now and make a lasting impact with the Amgen team.
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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R&D Quality Senior Manager — In this vital role the R&D Quality Senior Manager will play a crucial part in ensuring our organization\'s compliance with regulatory standards and preparing and coordinating a cross-functional team for Regulatory Health Authority inspections globally. The role also involves developing inspection management plans for each identified Regulatory Health Authority inspection, managing the R&D inspection framework, and ensuring appropriate inspection resourcing and alignment across time zones. Additionally, the individual will support Regulatory Inspection Intelligence processes and contribute to operational quality initiatives. The Clinical Quality Inspection team is a diverse international team within the Global R&D Quality organization and is responsible for strengthening and enhancing the R&D Quality Inspection Management System, providing Quality oversight on R&D processes, and leading activities related to GCP regulatory inspections.
Responsibilities
Ensures, that because of inspection preparation activities, story boards are developed for key processes and activities and organizes presentations of the story boards and mock interviews in preparation of potential Sponsor inspections.
Ensures that a cross-functional team (e.g. Quality, Clinical Operations, other functional areas, PV/GPS, GRAAS, DTI, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management to provide real-time, proactive advice and guidance.
Raises potentially significant inspection findings/compliance risks/impact to Senior Management.
Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
Manage the R&D inspection Framework (Calendars, Distribution Lists, Inspection notifications, SharePoint Sites, Training Content, etc).
Liaise with R&D Quality TA Leads to develop appropriate inspection resourcing/scaling and facilities across time zones, and align TA compliance risk identified contact (CT-RACT, specific risk management items e.g. imaging approaches).
Support Regulatory Inspection Intelligence processes and provide input into Operational Quality Initiatives.
What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:
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
Degree Educated
Extensive experience in inspection management within the pharmaceutical or biotechnology industry
Strong knowledge of global regulatory requirements and inspection processes
Excellent communication and presentation skills
Proven ability to work effectively in a cross-functional team environment
Strong organizational and project management skills
Experience with SharePoint and other inspection management tools
Ability to provide proactive advice and guidance on inspection management
Strong problem-solving skills and the ability to raise issues effectively
Ability to travel domestically and/or internationally, depending on business needs, to attend inspections as needed
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, 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, comprising 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. This 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 now and make a lasting impact with the Amgen team.
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.
#CLOLI
#J-18808-Ljbffr