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.

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.

Manager, Quality Assurance – Regulatory Affairs

Key skills