Manager, Quality Assurance – Regulatory Affairs

🕒 May 7

🏈 Alabama, California, +14 more states – Remote

🏈 Alabama – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🏛️ District of Columbia – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🌪️ Kansas – Remote 🏖️ New Jersey – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote 🌲 Oregon – Remote 🍂 Massachusetts – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote 🤠 Texas – Remote ⚔️ Virginia – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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PerkinElmer

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1938

🔬 Science

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Science • Pharmaceuticals • Healthcare Insurance

PerkinElmer is a global leader in providing analytical and testing solutions for a wide range of industries, including pharmaceuticals, food safety, environmental analysis, and industrial testing. The company offers advanced equipment and consumables, including mass spectrometers, chromatography instruments, and spectroscopy systems. With over 85 years of experience, PerkinElmer is committed to innovation and dedicated to partnering with laboratories worldwide to enhance scientific discovery and ensure product quality and safety. Their services support industries like healthcare, food and beverage, environmental testing, and industrial applications, helping clients meet compliance and quality standards.

📋 Description

• Serve as a delivery leader on tactical quality and regulatory engagements, including but not limited to: Quality Management System (QMS) remediation, Investigation activities, Submission support, Supplier Quality Audits, New Product Introduction QA/RA support. • Ensure delivery excellence, regulatory rigor, and strong client outcomes across all engagements. • Maintain high billable utilization consistent with consulting expectations. • Travel as required to support client projects and audits. • Identify opportunities to expand existing engagements into broader or deeper quality and regulatory programs. • Actively contribute to PF’s reputation as a leader in quality and regulatory consulting.

🎯 Requirements

• Bachelor's degree in scientific, regulatory, engineering, or related discipline preferred. • 10 years (Manager) -17 years (Sr. Mgr) of experience in life sciences quality, compliance, or regulatory roles, including consulting and/or owner-side leadership. • Demonstrated success delivering and advising on complex GxP, regulatory, and quality system initiatives. • Strong working knowledge of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO). • Proven ability to support sales and business development in a consulting environment. • Executive presence with strong written and verbal communication skills. • Willingness and ability to travel regularly in support of project delivery and client needs. • Strong communicator and influencer across multiple disciplines. • Is able to easily achieve agreement and collaborative resolution to project issues. • Structured thinker with advanced troubleshooting and problem-solving skills. • Skilled at managing multiple priorities in a high pressure, regulated environment. • Ability to manage scope and track project changes • Demonstrated leadership and mentorship abilities. • Applicants must be authorized to work in the United States on a full-time basis.

🏖️ Benefits

• PerkinElmer is committed to creating a diverse environment • Equal opportunity employer