Implementation Manager
WEX
Manager, Product Quality
Amgen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $113,373 - $138,602 per year
Job Level
SeniorLead
About the role
- Engage with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities
- Support product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections
- Provide effective, cross-functional quality support for program results for late phase and commercial programs, including actions required for the annual product reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author PQ-owned regulatory filing sections and RTQs
- Support science and risk-based evaluation of complex process and product quality data and develop patient-oriented strategies that account for business needs
- Project management of select aspects of Product Quality or broader Product Lifecycle Quality
- Own, author and review GMP and regulatory documents, execute transactions in relevant GMP systems, and manage product data including comparability assessments, annual product reviews, and product quality risk assessments
- Contribute to initiatives intended to ensure the overall product health
Requirements
- Doctorate degree OR Master’s degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience OR Bachelor’s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience OR Associate’s degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience OR High school diploma / GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience
- B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field (preferred)
- Experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment (preferred)
- 4+ years working in a regulated environment (either direct GMP or technical support) with experience working with biologic products (preferred)
- 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation (preferred)
- Experience with GMP systems and execution of GMP transactions
- Ability to author and review GMP and regulatory documents
- Experience performing comparability assessments, annual product reviews, and product quality risk assessments
- Project management experience for product quality or product lifecycle activities
- Cross-functional collaboration with Regulatory, Process Development, Quality Assurance, Quality Control, and International Distribution Quality
Benefits
- A 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
- Health and welfare plans for staff and eligible dependents
- Financial plans with opportunities to save towards retirement or other goals
- 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
- Flexible work models, including remote and hybrid work arrangements, where possible
- Work/life balance and career development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMPregulatory documentationcomparability assessmentsannual product reviewsproduct quality risk assessmentsanalytical methodsprocess developmentquality controlquality assurancebiologic products
Soft skills
cross-functional collaborationproject managementeffective communicationproblem-solvingstrategic thinking
