Career CategoryQuality
Job DescriptionQUALITY COMPLIANCE, DIRECTORWhat you will doLet's do this. Let's change the world. In this vital role you will report to the Executive Director of Regulatory Compliance and primarily provide direct support for compliance related deliverables associated to new sites or expansion of existing manufacturing sites.
- Serve as a strategic partner supporting the Quality Improvement Plans (QIP) and Operational Readiness program by providing independent compliance expertise, and objective guidance to support sustained GMP readiness and operational excellence.
- Partner closely with QA Operational Readiness Team and cross-functional leadership to evaluate remediation strategies, operational readiness initiatives, and quality system enhancements, ensuring alignment with global quality standards, regulatory expectations, and enterprise best practices.
- Participate in operational readiness reviews, and Go/No-Go decision-making processes to support objective, evidence-based assessments while promoting inspection readiness, effective risk management, and the long-term sustainability of the site's Quality Management System.
- Draft and/or review regulatory communications in the form of inspection observation responses, third party audit finding responses, responses to questions associated with regulatory filings and other information requests.
- Conduct inspection readiness exercises (strategy, preparation, pressure testing) in support of both scheduled and unscheduled regulatory inspections, in coordination with the sites and Site Inspection Lifecycle Management staff.
- Assist with generation of inspection playbooks and ensure staff are prepared to present during regulatory inspections.
- Lead virtual or on-site strategy support during regulatory inspections. May lead cross-functional regulatory response teams.
- Provide direct compliance support for deviation investigation and key inspection topics. Ensure appropriate technical content and documented rationale is available in support of investigation conclusions. Participate on Investigation Advisory Boards as Advisor, as required.
- Provide compliance advice on new technologies and proposed changes to quality processes in support of continuous improvement and the implementation of new digital strategies.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.
Basic Qualifications:- Bachelor's degree and 9 years of Quality Compliance experience OR
- Master's degree and 7 years of Quality Compliance experience OR
- Doctorate degree and 4 years of Quality Compliance experience
Preferred Qualifications:- Strong background in Quality Compliance within a GMP-regulated environment.
- Experience supporting drug substance and bulk manufacturing operations.
- Expertise in GMP compliance, inspection readiness, and regulatory requirements.
- Experience with drug product manufacturing and compliance.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
- 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
- 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range170,460.70USD -230,623.30 USD
