Senior Director - Quality Assurance & Regulatory Affairs

PerkinElmer, Inc.

Job Overview

Location

US Remote - NC

Job Type

Full-time

Full Job Description

📋 Description

• As Senior Director of Quality Assurance & Regulatory Affairs at PerkinElmer’s Project Farma, you will lead a strategic Center of Excellence focused on delivering high-value, complex quality and regulatory consulting services to life sciences clients, directly impacting patient outcomes by accelerating the delivery of life-changing therapies through expert guidance on compliance, inspection readiness, and regulatory strategy.
• You will serve as a senior advisor and delivery leader on mission-critical engagements including Quality Management System design and remediation, inspection readiness and mock inspections, regulatory responses, data integrity and risk management, quality governance, investigation responses, submission support, FDA-facing meetings, supplier quality audits, new product introduction, investigation system development, Quality Management Maturity Model assessments, and regulatory strategy—ensuring clients achieve and maintain continuous compliance readiness in high-pressure environments.
• You will drive business growth by leading or contributing to proposal development, scope definition, pricing, and client presentations; identifying opportunities to expand engagements into broader quality and regulatory programs; and representing the firm at industry forums (ISPE, PDA, ASQ, RAPS) to build thought leadership through white papers, frameworks, case studies, and internal methodologies that reinforce PerkinElmer’s reputation as a trusted advisor.
• You will mentor and coach consultants and project managers across the organization, support talent development and capability-building initiatives, maintain high billable utilization consistent with senior consulting expectations, and collaborate with Regional VPs, Client Engagement, and Client Solutions teams to align resources with strategic client needs while fostering a culture of integrity, humility, customer focus, and continuous improvement.
• You will shape enterprise-level strategy, develop leadership talent, balance short-term execution with long-term growth, and ensure operational excellence by translating evolving global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO) into actionable guidance—while embodying Project Farma’s Patient Focused and People First values through curiosity, personability, and unselfish collaboration.

🎯 Requirements

• Bachelor’s Degree (and/or Masters) in Life Sciences, Engineering, Regulatory, or related discipline OR equivalent experience in quality assurance, cGMP facility start-up, regulatory assurance, military, or professional services.
• Minimum 16+ years of directly relevant experience in delivering and advising on complex GxP, regulatory, and quality system initiatives.
• Strong working knowledge of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO) and 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 for client projects and regulatory-facing activities.
• Advanced degree preferred; current residence in a Project Farma primary market location is advantageous.

🏖️ Benefits

• Competitive annual compensation range of $160,000 to $180,000, with final base pay determined by internal equity, location, qualifications, skills, experience, and education.
• Opportunity to work remotely (US Remote - NC) with a global leader in scientific solutions backed by over 80 years of innovation and a mission to innovate for a healthier world.
• Access to a global service network, distribution centers, and OneSource services, enabling delivery of critical customer solutions at the right time.
• Professional growth through mentorship, knowledge sharing, ongoing development, and thought leadership opportunities at industry conferences and professional societies.
• Commitment to diversity, equity, and inclusion as an equal opportunity employer with a culturally diverse workforce and no visa sponsorship for this role.

Skills & Technologies

Senior

Remote

Degree Required

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PerkinElmer, Inc.

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About PerkinElmer, Inc.

PerkinElmer, Inc. is a global leader in applied, integrated solutions that help customers solve complex analytical challenges. The company provides innovative technologies and services for the life sciences, diagnostics, and applied markets. Its offerings include instruments, reagents, software, and services that support research, drug discovery, clinical diagnostics, and environmental testing. PerkinElmer's mission is to enable scientists and clinicians to make discoveries that improve the health and well-being of people worldwide. With a commitment to scientific excellence and customer collaboration, the company plays a crucial role in advancing scientific understanding and improving human health outcomes across various industries.

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