Engineer III, Quality Assurance & Regulatory Affairs

About Project Farma

Project Farma, a PerkinElmer company, is dedicated to improving patient lives by accelerating the delivery of life-changing therapies through high-quality life sciences projects. Our team collaborates with cross-functional teams to build trusted client relationships, deliver exceptional customer experiences, and drive business growth using data-driven insights for project planning, cost, schedule, and performance management.

This role contributes to organizational success by supporting financial performance, operational efficiency, and continuous improvement, while also investing in people through mentorship, knowledge sharing, and professional development. All team members are expected to embody Project Farma’s values: curious, personable, and unselfish, with a strong commitment to a Patient Focused and People First mindset.

Role Overview

The Engineer III, Quality Assurance & Regulatory Affairs is a client-facing consultant responsible for delivering and growing high-value quality, compliance, and regulatory services. This is a tactical, delivery-first role with a strong emphasis on complex, high-impact engagements rather than routine or transactional work.

The role is expected to maintain high billable utilization, with time allocated as needed to support business development and industry thought leadership. The Engineer serves as a trusted advisor and problem solver to clients, a mentor to consulting staff, and a visible contributor to the firm’s market reputation in quality and regulatory excellence.

The Engineer III role provides a seniority ladder leading to Lead Quality Engineer who may be expected to manage client projects and provide team leadership. At the Lead level, the engineer is expected to primarily work independently.

Key Responsibilities

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) assessment and remediation
  • Inspection readiness, mock inspections, inspection training
  • Data integrity, risk management, and compliance transformation
  • Quality governance and organizational effectiveness
  • Investigation responses
  • Submission support
  • Supplier Quality Audits
  • Investigation system back log remediation.
• Prioritize tactical, complex projects as the preferred engagement type; avoid routine or staff-augmentation-only assignments where possible.
• Ensure delivery excellence, regulatory rigor, and strong client outcomes across all engagements.

Billable Utilization & Project Leadership

• Maintain high billable utilization consistent with senior consulting expectations.
• Travel as required to support client projects, executive workshops, audits, and regulatory-facing activities.

Business Development & Market Support

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

Experience Required

• Bachelor’s degree in scientific, regulatory, engineering, or related discipline preferred.
• 3-7 years of experience in life sciences quality, compliance, or regulatory roles, including consulting and/or owner-side leadership.
• Demonstrated success delivering intermediate GxP, regulatory, and quality system initiatives.
• Strong working knowledge of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO).
• 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

• Advanced Degree preferred

Additional Information

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position.

This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.