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Manager Quality, Operations (2Nd Shift)

Company

Amgen

Address , New Albany, Oh
Employment type FULL_TIME
Salary $110,575 - $136,766 a year
Expires 2023-06-09
Posted at 1 year ago
Job Description
Career Category
Quality
HOW MIGHT YOU DEFY IMAGINATION?
You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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
IMPORTANT: This role is a 2nd shift work schedule and requires local presence at the New Albany site near Columbus, Ohio.
Live
What you will do
Let’s do this! Let’s change the world! In this vital role you will be managing the Plant Quality Assurance (PQA) team, responsible to oversee 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 oversees 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 supervise an impactful PQA team supporting manufacturing in a shift structure that may include second, third and/or weekend as a normal schedule.
  • Interact with Manufacturing, Process Development and other stakeholders for escalated cases of deviations related to process, equipment or materials.
  • 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.
  • Provide oversight of the QMS process implementation applied in manufacturing, including deviation management, CAPAs, work-orders and change controls.
  • Responsible for selection, training, evaluation, staff relations and development of staff. Interacts with management in optimizing organizational structure and responsibilities.
  • 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.
  • Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
  • 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.
Win
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:
Doctorate degree
Or
Master’s degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry
Or
Bachelor’s degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry
Or
Associate’s degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry
Or
High school diploma / GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry
And
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
  • Familiarity with equipment commissioning and qualification activities
  • Strong in managerial skills, coaching, mentoring and counseling
  • Experience in a GMP controlled environment
  • Strong organizational skills, including ability to follow assignments through to completion
  • Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
  • Educational background in life sciences or equivalent
  • Affinity with digital innovation and data sciences
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
Thrive
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:
  • Flexible work models, including remote work arrangements, where possible
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Stock-based long-term incentives
  • 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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
.
Salary Range
110,575.00 USD - 136,766.00 USD