What are the responsibilities and job description for the Quality Assurance 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. 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, 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 Assurance Senior Manager
What You Will Do
Lets do this. Lets change the world. In this role of Quality Senior Manager you will be responsible for quality oversight of multiple secondary packaging components external suppliers which provide global goods and services to Amgen. You will be part of a multifunctional team and work within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. You will work closely with External Supply, Process Development, Combination Product Quality, and various other parts of Operations. This role also has regional responsibilities across multiple manufacturing sites. The Quality Senior Manager will report into Associate Director of External Supply Quality for North America. This role can be filled in multiple locations in US, but proximity close to Amgen's advanced packaging facility in Ohio is preferred. Travel may be required.
Key Responsibilities For This Role Include
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications
Basic Qualifications
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
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 diverse, 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 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.
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. 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, 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 Assurance Senior Manager
What You Will Do
Lets do this. Lets change the world. In this role of Quality Senior Manager you will be responsible for quality oversight of multiple secondary packaging components external suppliers which provide global goods and services to Amgen. You will be part of a multifunctional team and work within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. You will work closely with External Supply, Process Development, Combination Product Quality, and various other parts of Operations. This role also has regional responsibilities across multiple manufacturing sites. The Quality Senior Manager will report into Associate Director of External Supply Quality for North America. This role can be filled in multiple locations in US, but proximity close to Amgen's advanced packaging facility in Ohio is preferred. Travel may be required.
Key Responsibilities For This Role Include
- Ensure appropriate quality oversight of suppliers in line with global regulations, defines quality requirements for suppliers and monitors performance
- Monitors and assigns quality status and, if required, determines remediation actions and additional oversight needed, including technical site visits
- Maintains key quality performance indicators for suppliers of responsibility
- Review and approval of quality records such as; Quality Agreements, supplier investigations, deviations, supplier change notifications, change controls, CAPAs, and CAPA-EVs
- Manage supplier audits to completion
- Act as point of contact for Amgen sites to resolve concerns and support projects regarding secondary packaging materials and suppliers
- Represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site
- Identify and mitigate risks at supplier site and raise to management as appropriate
- Onboard and offboard suppliers and/or manufacturing location as needed
- Lead departmental improvement projects regarding continuous improvement and automation
- Knowledge of Primary and Secondary packaging is a plus
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications
Basic Qualifications
- Doctorate degree and 2 years of Quality and Compliance experience OR
- Masters degree and 4 years of Quality and Compliance experience OR
- Bachelors degree and 6 years of Quality and Compliance experience OR
- Associates degree and 10 years of Quality and Compliance experience OR
- High school diploma / GED and 12 years of Quality and Compliance experience
- Educational background in Life Sciences
- Strong technical knowledge and experiencewithin operationsinthepharmaceutical orGMP-regulatedindustry
- Relevantwork experience within Drug Product and Finished Drug Product operations
- 5 years of experience overseeing quality of suppliers
- Robust problem-solving and root-cause analysis experience
- Strong continuous improvement mentality
- Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive withanend-to-end mentality
- Strong communicationskillswithproficiencyin the English language and collaborative cross-functionally behavior
- Strong report writing and presentation skills
- Experience drivingdecision-makingby using DAI principles
- Understanding of industry requirements/expectations of a QMS
- Savvy with data and Artificial Intelligence tools
- Understanding of the applicable manufacturing/testing processes (i.e.API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
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.
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 diverse, 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 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.