National Guard Employment Network
Director, Quality Assurance - Thousand Oaks, CA
National Guard Employment Network, Thousand Oaks, California, United States, 91362
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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. 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.
Director, Quality AssuranceWhat you will doLet's do this. Let's change the world. In this vital role you will be responsible for Quality oversight of manufacturing, lab, and supply chain operations leading a team of approximately 20 Quality staff. In addition, you will partner with Corporate Quality on Quality Systems representing the site and working across the network on key initiatives. As the Director, Quality Assurance you will help advance the site and quality network strategy, serving on the site Quality Leadership Team (QLT) and the Manufacturing and Clinical Supply (MCS) extended leadership team. This role will ensure product quality standards are met in compliance with Amgen and regulatory requirements.
Leads and directs all aspects of Quality Assurance (QA) for Amgen Thousand Oaks Drug Product Site Quality Operations, primarily Development Supply Chain, Synthetics, QA for Quality Control and Process Development, Quality Management Systems at the site, Incoming Quality Assurance, and site Audits/Inspection management.Ensures that pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations and specificationsImplements the Amgen Quality Management System across the responsible buildings and processes in accordance with corporate standardsPeriodically reviews performance metrics to identify, report, address and correct all quality risksEnsures that there is an adequate number of qualified personnel who possess an adequate combination of education, experience and training provided to perform assigned QA functions in accordance with requirements and specificationsEnsures Quality oversight of pharmaceutical product, production records, documents and proceduresServes as the QA representative to regulatory authorities, Amgen Corporate auditors, and 3rd party auditors for areas of responsibilityAlerts senior management of significant quality, compliance, supply and safety risksWorks in partnership with partner organization (e.g. Manufacturing, Quality Control, Supply Chain) leadership to assure quality of Amgen products complies with applicable regulations and specificationsSupports Continual Improvement initiatives, programs and projects of the Quality SystemCollaborates as a full member of the ATO Site Quality Leadership Team to ensure holistic management of Quality across the siteRepresents the site and assists Corporate Quality partners related to execution of the Quality Management System and corresponding initiatives
Additional Qualifications/Responsibilities
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a self starter with these qualifications.
Basic Qualifications:
Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
OR
Master's degree and 8 years of Quality/Manufacturing/Engineering experience
OR
Bachelor's degree and 10 years of Quality/Manufacturing/Engineering experience
AndIn addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Bachelor's Degree in a Life Science field15 + years' pharmaceutical industry experiencePrevious experience in Quality oversight of Synthetics manufacturing or Clinical Supply Chain operationsStrong knowledge of cGMPs and experience interacting with RegulatorsAble to drive process improvement within area of responsibilityAble to successfully manage workload to timelinesLeadership and communication skillsWhat you can expect of usAs 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, 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possible
Salary Range187,972.00 USD - 214,012.00 USD
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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. 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.
Director, Quality AssuranceWhat you will doLet's do this. Let's change the world. In this vital role you will be responsible for Quality oversight of manufacturing, lab, and supply chain operations leading a team of approximately 20 Quality staff. In addition, you will partner with Corporate Quality on Quality Systems representing the site and working across the network on key initiatives. As the Director, Quality Assurance you will help advance the site and quality network strategy, serving on the site Quality Leadership Team (QLT) and the Manufacturing and Clinical Supply (MCS) extended leadership team. This role will ensure product quality standards are met in compliance with Amgen and regulatory requirements.
Leads and directs all aspects of Quality Assurance (QA) for Amgen Thousand Oaks Drug Product Site Quality Operations, primarily Development Supply Chain, Synthetics, QA for Quality Control and Process Development, Quality Management Systems at the site, Incoming Quality Assurance, and site Audits/Inspection management.Ensures that pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations and specificationsImplements the Amgen Quality Management System across the responsible buildings and processes in accordance with corporate standardsPeriodically reviews performance metrics to identify, report, address and correct all quality risksEnsures that there is an adequate number of qualified personnel who possess an adequate combination of education, experience and training provided to perform assigned QA functions in accordance with requirements and specificationsEnsures Quality oversight of pharmaceutical product, production records, documents and proceduresServes as the QA representative to regulatory authorities, Amgen Corporate auditors, and 3rd party auditors for areas of responsibilityAlerts senior management of significant quality, compliance, supply and safety risksWorks in partnership with partner organization (e.g. Manufacturing, Quality Control, Supply Chain) leadership to assure quality of Amgen products complies with applicable regulations and specificationsSupports Continual Improvement initiatives, programs and projects of the Quality SystemCollaborates as a full member of the ATO Site Quality Leadership Team to ensure holistic management of Quality across the siteRepresents the site and assists Corporate Quality partners related to execution of the Quality Management System and corresponding initiatives
Additional Qualifications/Responsibilities
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a self starter with these qualifications.
Basic Qualifications:
Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
OR
Master's degree and 8 years of Quality/Manufacturing/Engineering experience
OR
Bachelor's degree and 10 years of Quality/Manufacturing/Engineering experience
AndIn addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Bachelor's Degree in a Life Science field15 + years' pharmaceutical industry experiencePrevious experience in Quality oversight of Synthetics manufacturing or Clinical Supply Chain operationsStrong knowledge of cGMPs and experience interacting with RegulatorsAble to drive process improvement within area of responsibilityAble to successfully manage workload to timelinesLeadership and communication skillsWhat you can expect of usAs 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, 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possible
Salary Range187,972.00 USD - 214,012.00 USD