Senior QA Manager
Amgen
full-time
Posted on:
Location Type: Office
Location: Holly Springs • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $149,379 - $182,031 per year
Job Level
Senior
About the role
- Lead, manage, and motivate a high-performing team of Quality professionals supporting Disposition and Incoming Quality
- Provide technical quality leadership and oversight of Disposition and Incoming Quality operations at the North Carolina site
- Partner closely with cross-functional teams to build, enhance and sustain compliant commercial operations
- Ensure team members are properly trained and qualified to perform duties in accordance with cGMP and regulatory requirements
- Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring
- Own development, implementation, and continuous improvement of the site's inspection readiness program and Quality Management System (QMS)
- Ensure timely review, approval, and tracking of cGMP processes, documents, and records (deviations, CAPAs, Change Controls, validation protocols, assays)
- Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact
- Stay current with regulatory developments and quality trends to maintain a compliant quality program
- Represent the Quality unit during internal and external audits and regulatory inspections
- Alert senior management to significant quality, compliance, supply, or safety risks and coordinate cross-functionally
- Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline
Requirements
- High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR Associate’s degree and 10 years of Quality and Manufacturing support industry experience OR Bachelor’s degree and 8 years of Quality and Manufacturing support industry experience OR Master’s degree and 6 years of Quality and Manufacturing support industry experience OR Doctorate degree and 2 years of Quality and Manufacturing support industry experience
- Educational background in Life Science and/or Engineering (preferred)
- Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems
- In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing
- Hands-on experience with Disposition, Incoming, and Quality Systems—particularly investigations, corrective actions, and audit readiness
- Experience managing and interacting with regulatory and internal auditors
- Demonstrated leadership of Quality teams, with team development, collaboration, and mentoring skills
- Effective risk management, negotiation, and cross-functional collaboration abilities
- Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish
Benefits
- Total Rewards Plan comprising health and welfare plans for staff and eligible dependents
- Financial plans with opportunities to save towards retirement or other goals
- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program (or sales-based incentive plan for field sales representatives)
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
- Competitive benefits, 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
Quality Management System (QMS)cGMPregulatory requirementsdeviationsCAPAsChange Controlsvalidation protocolsassaysquality systemspharmaceutical processing
Soft skills
leadershipteam developmentcollaborationmentoringrisk managementnegotiationcross-functional collaborationwritten communicationverbal communicationpresentation skills