QA/RA Lead Engineer - Project Farma

PerkinElmer•Westwood, MA

1d•$100,000 - $120,000•Remote

About The Position

This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will work remotely and be willing to travel domestically to meet client project requests, including short-term full time work on client sites. Project Farma’s purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support 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 by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset. The QA/RA - Lead Engineer is an advanced individual contributor with demonstrated depth in their technical discipline and a growing record of leading complex workstreams. This role applies strong subject‑matter expertise to solve high‑impact technical and operational challenges, supports technical decision‑making, and contributes to the evolution of standards, methods, or best practices within their area. The Lead Engineer works with a high degree of independence, mentors junior and peer engineers, and partners closely with project and people leaders—while remaining focused on technical delivery rather than formal people management.

Requirements

Bachelor’s degree in scientific, regulatory, engineering, or related discipline preferred.
7-10 years of experience in life sciences quality, compliance, or regulatory roles, including consulting and/or owner-side leadership.
Demonstrated success delivering advanced cGMP/GCP/GLP, 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 to travel as required for client project assignments.
Applicants must be authorized to work in the United States on a full-time basis.
We cannot employ anyone with an invalid driver's license.

Nice To Haves

Advanced Degree preferred
Experience with front/back-room operations for regulatory inspections
Demonstrated leadership and mentoring abilities

Responsibilities

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.
Maintain high billable utilization consistent with senior consulting expectations.
Travel as required to support client projects, executive workshops, audits, and regulatory-facing activities.
Identify opportunities to expand existing engagements into broader or deeper quality and regulatory programs.
Mentor and guide lower graded individuals.