HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Executive Director Quality, Final Product Technologies Quality
What you will do
Lets do this. Lets change the world. In this vital role you will lead the strategy and execution for Quality oversight of combination products at Amgen.
This position reports to the Vice President of Final Product Quality and Surveillance. This individual closely partners with process development, safety, and regulatory counterparts to ensure successful development of regulatory submissions and setting of specifications and inspection readiness globally.Alerts and advises senior management on significant Quality, compliance, supply and safety risks. Provides authoritative advice to executive management based on deep subject matter expertise in Final Product, Combination Product and device Quality.
Accountable to develop and lead a team that provides Quality technical expertise for all aspects of combination products and devices lifecycle. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform assigned Quality oversight of final products, combination products and devices in accordance with requirements and specifications.
Responsibilities include oversight of final product quality including device functionality (designing and maintaining over the lifecycle) while maintaining quality of the active pharmaceutical ingredient within the device (i.e. quality from the health care providers and patients perspective)
- Accountable for quality oversight throughout the final product and combination products lifecycle from development through end of asset including post-approval changes globally
- For device constituent of combination products, this will include Design Control, design verification, biocompatibility, functional stability, registration and listing across all sites
- Develop and maintain effective relationships with external partners to influence policy for final products, combination products / devices
- Ensure compliance and adherence to Amgens standards, cGMPs, and global regulatory agency guidelines for device and combination product design and development
- Oversee inspections by notified bodies
- Ensure reliable and agile Quality systems associated with device design and development
- Provide advice for in vitro diagnostic device (IVD) and digital health compliance. Develops and maintains effective internal relations with Device Functional leads, PQLs and other technical/regulatory experts within Operations and R&D
- Develop and maintain Final Product Quality international engagement strategy
- Develop and provide oversight for the development of departmental budgets and expenditures
- Ensure appropriate identification of critical events and escalation per business process
- Contribute to inspection readiness activities
- Lead cross-functional initiatives
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a Leader with these qualifications.
- Doctorate degree & 6 years of Quality, Regulatory or Device Design experience, OR
- Masters degree & 10 years of Quality, Regulatory or Device Design experience, experience, OR
- Bachelors degree & 12 years of Quality, Regulatory or Device Design experience, experience AND
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Advanced degree in Biology, Pharmaceutics, Biotechnology, Engineering, Physics or related discipline.
- 15+ years of experience within the pharmaceutical/biotechnology industry
- Combination product expertise and experience include functional knowledge of applicable guidance, regulations and standards e.g. ISO 14971, ICH Q9, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211
- Practical knowledge of combination product and device engineering
- Strong expertise in combination product regulations internationally
- Experience with or having been involved in a Complete Response Letter
- Problem solving, trouble shooting, and communication skills
- Promote growth (develop leaders) and provide the tools to develop the next generation of leaders
- Make risk-based decisions based with an enterprise-wide mindset and decision-making processes that reflect Quality beyond compliance
- Display a continuous improvement attitude by constantly and directly challenging status quo within team and with peers
- Direct experience leading complex organizations and serving as a primary point of contact representing the organization with external agencies
- Demonstrated leadership in various quality functions
- Demonstrated ability to remain calm under duress or in stressful situations
- Deep and broad understanding of Quality including batch release, complaints, change control, design controls, risk management, etc.
- Ability to work effectively in global cross-functional teams and in a highly matrixed team environment. Drive change, efficiency, and strong cross-functional relationships
- Up to 25% Domestic and international travel may be required
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.
- Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
- 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
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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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.
Join UsIf 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.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.