HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Manager Quality, Operations (3rd Shift)Live
What you will do
Lets do this! Lets change the world! In this role you will be managing the Plant Quality Assurance (PQA) team, responsible to lead all aspects of the assembly and packaging operations. A key aspect of this role is to ensure quality and compliance to GMP regulations for all assembly and packaging operations.
The Manager PQA will play a key role in the Quality Assurance team, focused on building a strong PQA team and establishing efficient Plant Quality processes. The PQA team leads all aspects of quality of manufacturing operations (assembly and packaging) and is responsible for batch disposition of the produced Finished Drug Product at the site. Your team will work closely with the manufacturing team to assure product is produced according to quality standards and in alignment with the regulatory filing. The team assures the Finished Drug Product is dispositioned in a timely manner to supply every patient every time.
You will support all activities for the set-up of the new assembly and packaging area, working closely with manufacturing to define production processes using a risk-based approach. You will build and own an impactful PQA team supporting manufacturing in a shift structure that may include second, third and/or weekend as a normal schedule.
- Own the realization of operational activities for PQA while providing technical expertise/guidance to the staff and ensuring Finished Drug Product is dispositioned in a timely manner; handle daily operations in relation to planning and management of the team and their tasks.
- Responsible for selection, training, evaluation, staff relations and development of staff. Interacts with management in optimizing organizational structure and responsibilities.
- Provide oversight of the QMS process implementation applied in manufacturing, including deviation management, CAPAs, work-orders and change controls.
- Interact with Manufacturing, Process Development and other partners for raised cases of deviations related to process, equipment or materials.
- Ensure that all operations follow applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
- Own and review related SOPs, methods, protocols and reports. Provide training and oversight for staff.
- Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
- Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for equipment implementation. Drive Lean Transformation and Operational Excellence initiatives.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.Basic Qualifications:
Masters degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry
Bachelors degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry
Associates degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry
High school diploma / GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:
- Educational background in life sciences or equivalent
- Strong in managerial skills, coaching, mentoring and counseling
- Experience in a GMP controlled environment
- Familiarity with equipment commissioning and qualification activities
- Affinity with digital innovation and data sciences
- Excellent written and verbal communication, ability to work in a team matrix environment and build relationships with partners
- Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
- Strong organizational skills, including ability to follow assignments through to completion
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $110,575-$136,766.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.