Manager, Quality Assurance – Regulatory Affairs

This is a fully remote position, open to applicants in Alabama, +15 more states.

📋 Description

• Act as a leader for the delivery of tactical quality and regulatory projects, which encompass: Quality Management System (QMS) remediation, investigation activities, submission support, supplier quality audits, and QA/RA support for new product introductions.

• Ensure exceptional delivery, regulatory compliance, and positive client outcomes throughout all projects.

• Maintain high levels of billable utilization in line with consulting standards.

• Travel as necessary to assist with client projects and audits.

• Identify avenues to broaden or deepen existing engagements into more extensive quality and regulatory programs.

• Contribute actively to the enhancement of PF’s reputation as a leader in quality and regulatory consulting.

⛳️ Requirements

• A bachelor's degree in a scientific, regulatory, engineering, or related field is preferred.

• 10 years of experience for Manager roles and 17 years for Senior Manager roles in life sciences quality, compliance, or regulatory positions, including consulting and/or owner-side leadership.

• Proven track record of delivering and advising on complex GxP, regulatory, and quality system initiatives.

• Strong understanding of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO).

• Demonstrated capability in supporting sales and business development within a consulting framework.

• Executive presence complemented by strong written and verbal communication skills.

• Willingness and capacity to travel frequently to meet project delivery and client requirements.

• Excellent communicator and influencer across various disciplines.

• Capable of achieving consensus and collaborative resolutions for project challenges.

• Structured thinker with advanced troubleshooting and problem-solving abilities.

• Proficient in managing multiple priorities in a high-pressure, regulated environment.

• Ability to manage project scope and monitor changes effectively.

• Demonstrated leadership and mentoring skills.

• Applicants must possess authorization to work in the United States on a full-time basis.

🏝️ Benefits

• PerkinElmer is dedicated to fostering a diverse environment.

• Equal opportunity employer.