Manager, Quality Assurance & Regulatory Affairs

Tactical Client Delivery (Primary Focus)

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.

Billable Utilization & Project Leadership

Maintain high billable utilization consistent with consulting expectations.

Travel as required to support client projects and audits.

Act as senior engagement contributor.

Business Development & Market Support

Identify opportunities to expand existing engagements into broader or deeper quality and regulatory programs.

Thought Leadership & Market Presence

Actively contribute to PF’s reputation as a leader in quality and regulatory consulting.

Remain at the forefront of US, EMA, and ROW regulatory changes and current expectations.

Attributes for Success

• Technical Delivery: Applies advanced technical knowledge and professional expertise
• Innovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas
• Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Integrity & Humility: Demonstrates self-awareness and puts PF mission above ego
• Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients
• Project Execution: Delivers reliably, manages priorities and drives for high quality outcomes
• Growth Mindset: Shows openness to new ideas, feedback and change

Experience Required

• 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.

Other Preferred

• Strong communicator and influencer across multiple disciplines.
• 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.