Senior Quality Assurance Manager

🔥 0 minutes ago

🏄 California, Florida, +2 more states – Remote

🏄 California – Remote 🐊 Florida – Remote 🍂 Massachusetts – Remote ⚓ Rhode Island – Remote

💵 $132k - $178.6k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Provide quality oversight of primary component suppliers • Act as quality lead for supplier relationships from onboarding through disengagement • Monitor supplier performance through proactive monitoring, technical site visits, and continuous improvement • Ensure supplier compliance with global regulatory standards including GDP, GMP, and ISO • Negotiate and own quality agreements • Prepare external sites for inspections, including inspection playbooks • Represent Amgen at supplier sites during regulatory inspections and notified body audits • Present inspection topics and demonstrate knowledge of subject areas • Review and approve supplier investigations, events, and change notifications • Approve deviations, change controls, CAPA, and CAPA EVs • Identify and mitigate supplier risks or escalate them to management • Perform Person in Plant activities as appropriate • Drive audit commitments to completion • Lead supplier audit preparation and identify focus areas • Assess supplier status through periodic monitoring reports • Partner with Operations site leads on issues, improvements, site performance, and relationship management • Implement GMP requirements internally and externally

🎯 Requirements

• Doctorate degree and 2 years of Quality experience OR Master’s degree and 4 years of Quality experience OR Bachelor’s degree and 6 years of Quality experience OR Associate’s degree and 10 years of Quality experience OR high school diploma/GED and 12 years of Quality experience • 10+ years biotech or pharmaceutical industry experience • 5+ years of experience overseeing quality of suppliers • Experience with leading audits • Technical knowledge related to primary components • Experience with Quality Processes and systems such as Trackwise and Veeva • Experience with quality oversight of primary components • History of presenting during inspections and audits • Ability to facilitate and influence senior stakeholders and partners • Ability to prioritize workload and meet timelines • Ability to negotiate a strategic position after receiving feedback from multiple sources • Strong project management, problem-solving, and analytical skills • Demonstrated ability to lead cross-functional teams and deliver timely, high-quality results • Ability to collaborate and communicate effectively with others, balance divergent inputs, and drive issue resolution • Ability to operate in a matrixed or team environment with site, functional, and executive leadership • Experience with relationship management with external parties • Savvy with data and Artificial Intelligence tools • Up to 20% domestic and international travel required

🏖️ Benefits

• Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance benefits • Health and welfare plans for staff and eligible dependents • Financial plans with opportunities to save towards retirement or other goals