Amgen Manager Quality Assurance / QP (full time / part time) in Tel Aviv, Israel
To lead the implementation, execution and on-going management of quality business requirements in support of the International and Distribution Quality business function.
Position Specific Tasks
Serve as Qualified Person for Amgen in Israel
This individual is the Qualified Person and the main contact for the pharmaceutical warehouse at the Distributor and serves an integral role within a cross-functional leadership team
Responsible for Quality oversight of activities for Amgen products in Israel, including product disposition, review and approval of Amgen specific quality documents, Deviations/CAPA, Change Controls
Additional responsibilities include management and evaluation of compliance issues/regulations, assure progress against commitments to regulatory agencies, identify compliance gaps and lead focused teams to resolve compliance issues, provide written compliance assessments to management on request, and interpret global regulations
Develop and maintain Quality System in Israel
Develop reports and provide the necessary communications throughout the organizations as required to ensure effective information sharing.
Support Amgen in all quality matters related to Amgen’s products imported and distributed in Israel,
As necessary, shall be the primary contact for the governmental agencies handling quality matters. He/She is authorized to represent Amgen in all matters related to governmental agencies handling quality matters (GDP inspections by Israeli Authority and Regional Health Inspectorate and other interactions with local Authorities)
Support other countries within the region
Cross-train with other peers and serve as back up for other countries within the region.
Degree in Pharmacy and qualifications of a QP
Fluency in Hebrew and English languages.
3 or more years of relevant work experience serving as Qualified Person within the pharmaceutical industry, preferably – experience with biologics, vaccines
Must have strong knowledge and understanding of the Israeli regulations in relation to Distribution, the European Pharmaceutical Directive related to Distribution of Medicinal Products, Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP)
Cold chain transportation and storage, local regulatory requirements
Experience in regulatory inspections
Experience in pharmaceutical equipment qualification, risk assessments, change control
Experience in providing support, troubleshooting unit operations, and resolving and documenting investigations to support GDP tasks
Good communication skills (Hebrew and English) technical writing and verbal communication/presentation
Interacts effectively with variety of communication and working styles and teams
Interact effectively with cross functional team
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
In-depth disciplinary knowledge; leverages business acumen and subject
matter expertise on GDP regulations (EU, Israel)
Contributes to the development of new techniques and plans within area of expertise
Applies advanced principles, theories and concepts, such as Six Sigma
Employs project management techniques
In-depth understanding of company goals and competitor practices
Thorough understanding of company business priorities, strategy and direction
Works on, and anticipates, abstract and complex problems requiring evaluation of intangible variables
Develops innovative and creative output based on interpretation and analysis
Develops methods and techniques based on project objectives
Work is guided by business plans for the discipline
Actively participates in setting function/department objectives to meet plans
Manages key projects or business processes
Guides completion of major projects
Contributes to the function/department through responsibility for delivery of end results and contribution to planning for the function/department
Uses strong relationships to identify requirements and potential opportunities
Provides leadership, guidance and advice in own field
Works with resource managers from across the organization to effectively obtain and allocate resources to complete programs and projects on time.
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.