Director, Quality Assurance

Company: Amgen Inc. (IR)
Location: Thousand Oaks
Posted on: November 15, 2024

Job Description:

Director, Quality Assurance Apply remote type On Site locations US - California - Thousand Oaks time type Full time posted on Posted Today job requisition id R-199828 Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving PatientsAt 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. What you will doIn 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. 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 specifications.
• Implements the Amgen Quality Management System across the responsible buildings and processes in accordance with corporate standards.
• Periodically reviews performance metrics to identify, report, address and correct all quality risks.
• Ensures 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 specifications.
• Ensures Quality oversight of pharmaceutical product, production records, documents and procedures.
• Serves as the QA representative to regulatory authorities, Amgen Corporate auditors, and 3rd party auditors for areas of responsibility.
• Alerts senior management of significant quality, compliance, supply and safety risks.
• Works in partnership with partner organization (e.g. Manufacturing, Quality Control, Supply Chain) leadership to assure quality of Amgen products complies with applicable regulations and specifications.
• Supports Continual Improvement initiatives, programs and projects of the Quality System.
• Collaborates as a full member of the ATO Site Quality Leadership Team to ensure holistic management of Quality across the site.
• Represents the site and assists Corporate Quality partners related to execution of the Quality Management System and corresponding initiatives. 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 And In 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 field
  • 15 + years' pharmaceutical industry experience
  • Previous experience in Quality oversight of Synthetics manufacturing or Clinical Supply Chain operations
  • Strong knowledge of cGMPs and experience interacting with Regulators
  • Able to drive process improvement within area of responsibility
  • Able to successfully manage workload to timelines
  • Leadership and communication skills What 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 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. 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. 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. Salary Range 187,972.00 USD - 214,012.00 USD About Us Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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Keywords: Amgen Inc. (IR), Buena Park , Director, Quality Assurance, Executive , Thousand Oaks, California