Manager QA - AML14
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
The AML-14 Facility is the home of best-in-class, multi-product Drug Product Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of being the best manufacturing facility in the world. Quality is woven into the fabric of everything we do and is the cornerstone of all our activities. We seek the highest quality information, decisions, and people, and we produce high quality products.
What you will do
Lets do this. Lets change the world. In this vital role you will be accountable to apply a combination of managerial skills and technical knowledge in a Good Manufacturing Practices drug product manufacturing environment to quickly assess facts and make appropriate decisions when process/product quality may be impacted.
Consistent with our core leadership value of Develops the Best Team, we are seeking leaders that prioritize the development of talent. We expect managers to exemplify strong leadership and champion self-awareness and career development.
- Direct management of on-the-floor QA activities including but not limited to oversight of the formulation and filling processes, batch record review, deviation investigation, change controls and SOP revisions, among others
- Strategic advisor to senior management of quality, compliance, supply, and safety risks
- Mentoring, coaching, and developing staff to build highly skilled, diverse, and inclusive teams
- Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
- Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
- Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
- Resolve critical gaps in the organizations internal capabilities and skillsets, including strategic external recruiting as needed
- Identifying diverse, qualified successors for key positions
- Ensure production in full cGMP compliance
- Ensure maintenance and re-validation of systems
- Collaborate with cross-functional teams (i.e. Manufacturing, Process Development, Regulatory, etc.) in completing production activities
- Review and approve product MPs, process validation protocols and reports for manufacturing processes
- Sponsor Continuous Improvement initiatives and projects
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Masters degree and 3 years of Quality or Manufacturing industry experienceOr
Bachelors degree and 5 years of Quality or Manufacturing industry experience
and previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.Beyond that, preferred qualifications are:
- Educational background in Life Science or Engineering
- Availability for Non-Standard Shift 12 hour Third shift
- GMP regulated industry experience
- Project management skills
- Initiate and lead cross functional teams
- Validated expertise in Quality Systems such as Non-Conformance, CAPA and Change Control
- Robust knowledge of and experience with processes involved in manufacturing, QA, and Process Development
- Strong organizational and change management skills
- Good communications skills (oral and written) in English and Spanish
- Enhanced skills in leading, influencing and negotiating
- Ability to motivate staff and manage and distribute workloads
- Demonstrate ability to interact with regulatory agencies
- Solid word processing, presentation, database and spreadsheet application skills
- Strong communication (both written and oral), facilitation and presentation skills
- Proven skills in working independently and to effectively interact with all levels throughout the organization
- Advanced data trending and evaluation
- Ability to evaluate compliance issues
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
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 a 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 an 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.