Amgen is hiring a Manager QA - Drug Substance to provide vital support to our Quality Assurance program on a non-standard night shift. You will lead and oversee the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico.
What You’ll Do
- Lead the Quality team for assigned plant(s) or functional area(s), overseeing staffing, training, supervision, and performance management.
- Ensure products are manufactured, tested, stored, and distributed in compliance with cGMP, GDP, and applicable regulations.
- Maintain compliance of facilities, equipment, materials, processes, procedures, and products with cGMP and regulatory standards.
- Review, approve, and track cGMP documentation, including NCs, CAPAs, Change Controls, validations, and assays.
- Approve Master Production Records, process validation protocols and reports, Environmental Characterization reports, and planned incidents.
- Represent QA in New Product Introduction teams and during audits and inspections.
- Lead investigations and plant audits; approve change-over completion activities.
- Ensure deviations are properly investigated and documented; verify accuracy and completeness of production records and test results.
- Collaborate cross-functionally to ensure QMS processes follow established procedures.
- Bring up quality, compliance, supply, and safety risks to senior management.
- Ensure controlled documents have assigned owners and that periodic reviews are completed on time.
What We’re Looking For
- Doctorate degree
- OR Master’s degree and 3 years of experience in regulated industry
- OR Bachelor’s degree and 5 years of experience in regulated industry
- OR Associate’s degree and 10 years of experience in regulated industry
- OR High school diploma / GED and 12 years of experience in regulated industry
- Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
Nice to Have
- Educational background in Life Sciences or Engineering
- Experience with processes involved with Quality Assurance, manufacturing and distribution, Quality Control, validation, and process development.
- Validated expertise in Quality Systems such as Deviations, CAPA and Change Control
- Experience leading cross functional teams with the influencing and negotiating skills
- Strong organizational, project management and change management skills
- Strong communication skills (both written and oral), and comprehension in English and Spanish
- Ability to provide direction and establish goals for individual staff members and work groups, empower staff, manage and distribute workloads.
- Ability to interact with regulatory agencies
Benefits & Compensation
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans and an annual site shutdown
- Flexible work models, including remote work arrangements, where possible
Work Mode
This role requires full-time onsite work at our facility in Juncos, Puerto Rico.
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.
