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Quality Director Global Post Market Actions and Surveillance

Company: Amgen SA
Location: Thousand Oaks
Posted on: January 13, 2022

Job Description:

If you feel like - you're - part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and deliverin g ever-better products that reach - over 10 million patients worldwide. It's time for a career you can be proud of. Join us. - - Quality Director Global Post Market Actions and - Surveillance - Live - What you will do - Let's do this. Let's change the world. The Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our biggest mission, to serve the patients. This vital role efficiently leads post market quality events and surveillance activities globally at Amgen, serving as the global process owner in the strategy and implementation of these critical processes. - - Responsibilities : - Assures systems and processes remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. Assure complaints - business - process is adapted to emerging trends or new requirements in regulations. - Trains and coaches SMEs on how to translate and deploy the requirements and QMS architecture to the sites or functional groups, informing them early of changes to ensure consistency. - P rovides guidance and technical advice to key partners to enable issues resolution. - Drives agile, efficient, effective and sustainable processes, KPIs and linkages between all multiple sources of post market activities. - Interfaces directly with agencies during inspections and provides response to agency requests regarding post market and surveillance/complaints processes. - - Provides leadership and support for regulatory inspections and audits by - coordinating critical activities to ensure compliance throughout the network: gap assessments, commitments, response to audit and inspection findings and deviations. - - D rives Operational Excellence and champions change by leading continuous process improvements and partnering with network SMEs on key initiatives. - - Leads all aspects of GMP Surveillance and takes actions to align process to applicable new or revised regulatory requirements -. H eads network and Owns Process Standard, Process Overview and Multisite SOP and ensures alignment with document hierarchy and document templates. - Applies knowledge and subject matter expertise to stimulate vital steps to advance the quality system to address complaint causes, etc. - Provides accurate and robust surveillance information that meets global health authorities and Amgen requirements. Communicates issues and action plans to management, demonstrating appropriate quality management systems to call out per business process, such as Management Review (MR). - Win - What we expect of you - Basic Qualifications : - Doctorate degree and 4 years of Quality or Operations experience - - OR - Master's degree and 8 years of Quality or Operations experience - OR - Bachelor's degree and 10 years of Quality or Operations experience - We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek has these qualifications: - 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry. - 7+ years of leadership experience leading teams across global sites and functions who have delivered on-time, and with high-quality results. - Understanding of applicable manufacturing/testing processes ( i.e. - API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls, Combination Products). - Ability to balance and interpret global priorities and market appropriate requirements to ensure Quality System elements are agile and phase appropriate. - Understand global, regional and local commercial business (speak commercial). - Innovation approach with aptitude for developing ideas into impactful objectives. - Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions. - Ability to broker a strategic position after taking feedback from multiple sources. Experience driving decision making. - Ability to succinctly communicate level of risk, priority, or impact to the business. - Ability to travel +/- 20% of time to domestic and international Amgen sites -. What you can expect of us - As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. - - Vast opportunities to learn and move up and across our global organization - Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act - Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits - Apply now - for a career that defies imagination - In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. - - Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. 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, or disability status. 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. Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen SA, Thousand Oaks , Quality Director Global Post Market Actions and Surveillance, Executive , Thousand Oaks, California

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