Amgen Global Safety Quality Management and Training Lead in Thousand Oaks, California
This group is responsible for the direction and strategy for signal detection, periodic reports and risk management activities. This includes driving policies/processes, performing research, defining and implementation of innovation and best practices for the following areas: safety data mining, signal detection planning, management, tracking; risk management practices, benefit/risk assessment and safety communications - while ensuring quality processes with proven metrics.
Position is responsible for strategic, operational, and quality support for Global Patient Safety (GPS) to ensure that an efficient Quality system is integrated into the management of safety processes and outputs. This position is also responsible for developing a capabilities road-map that aligns with the GPS strategies and delivering high-quality PV training compliant with internal SOPs and GVP Module I within a collaborative and matrix environment. Capabilities to be delivered include: Global Network relationship management, reporting and analytics, web sites and metrics, and change management.
Provide operational support to the Executive Director of Safety Management and other pharmacovigilance Business Process Owners (BPOs).
Advise Executive Director of Safety Management regarding strategic management of ongoing activities and processes that Safety Management uses to systematically coordinate and align resources and actions with mission, vision and strategy throughout safety function.
Provide framework and strategic oversight of functional training programs and oversees the process for the safety function; participates in development and modification of procedures and training material in collaboration with the BPOs and/or subject matter experts.
Oversee Quality Processes for the safety function which includes development of procedures in collaboration with BPOs.
Develop and interpret reporting and measurements for resource capacity planning for assigned functions within Safety.
Provide periodic management updates and reports and develops materials aligned with communication strategy and plan.
Liaise with the Strategic Planning and Ops Lead for Global Patient Safety for cross-GPS activities.
Oversee creation of metric control plans and maintenance for Safety Management.
Direct the efforts of Quality Control staff to most effectively support the fulfillment of Quality initiatives and strategic objectives in the Safety Organization.
Ensure performance and quality metrics are monitored in real time and available/communicated to all GPS senior management. When metrics fall out of the process limits, this position is responsible to work with key safety process owners to identify actions and ensure processes return to current state in a timely manner.
Responsible for developing and deploying continuous improvement elements and methods beyond metrics to an integrated view on safety function performance.
Initiate and manage initiatives targeted at improving process quality, effectiveness and creating a team culture of continuous improvement with process owners and leadership team.
Collaborate cross-functionally to conduct joint improvement initiatives to enhance interfaces and ensure harmonization across Amgen and business partners.
Ensure a globally aligned QMS approach by taking cross cultural aspects into consideration.
Liaise with QPPV office, R&D Quality and Compliance organizations as well as regions towards ensuring mutually beneficial quality solutions.
As Deviation Manager, accountable for tracking deviations to identified SOPs and forms through assessment, approval, and remediation.
Accountable for oversight of training activities globally in compliance with internal SOPs and GVP Module I.
Establish and maintain process standards and facilitate training opportunities across Therapeutic Area Safety roles.
Accountable for ensuring alignment of the function through the establishment and maintenance of process standards for Therapeutic Area Safety.
Fosters global process alignment through interactions with other BPOs cross-functionally and through Global Networks.
Establish, communicate and advise on business process strategies and present changes in appropriate forums.
Ensure consistency across therapeutic area teams on strategies pertaining to business process and training.
Partner with GPS leadership and Global Learning & Performance on developing a PV training strategy for Safety that can be delivered with high-quality, within financial guidelines and well supported with business resources.
Proactively engage advisory and executive steering committees to enable them to evaluate, change and/or endorse key project decisions.
Review and gain alignment of activities with other BPOs and Network groups.
Ownership of Change Management deliverables:
Develops and supports the communication management for training within GPS
Owns and manages the Communication Plan to drive change management, including delivery of consistent messaging and ongoing communications to engage the business and encourage adoption of changes
Assesses impact of change by tracking and monitoring defined KPIs
Identify, analyze and prepare risk mitigation in relation to change management
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
Education & Experience
Doctorate degree and 2 years of directly related experience Or
Master’s degree and 6 years of directly related experience Or
Bachelor’s degree and 8 years of directly related experience Or
Associate’s degree and 10 years of directly related experience Or
High school diploma / GED and 12 years of directly related experience
Master’s Degree with 6 years of experience (4 years PV and 2 years of relevant experience preferred); or BS, RPH, RN HCP, or Life Science with 8 or more years of experience (6 years PV and 2 years of relevant experience preferred)
Experience with Quality Control and Quality Assurance processes and systems
Proven experience in group facilitation – ability to guide teams to make decisions & achieve deliverables within agreed parameters & timescales
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses its 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.
Amgen is an Equal Opportunity employer and will consider you without regard to your 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.
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.