QA/RA Lead Engineer - Project Farma

QA/RA Lead Engineer - Project Farma PerkinElmer - 3.6 Kenilworth, NJ Job Details Full-time $100,000 - $120,000 a year 7 hours ago Qualifications Pharmaceutical regulatory compliance ICH guidelines Driver's License FDA regulations Full Job Description 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. Key Responsibilities This is a client-facing consultant responsible for delivering and growing high-value quality, compliance, and regulatory services across Project Farma's client base. 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 Lead 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. 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. Mentoring & Development of Engineers I-III Mentor and guide lower graded individuals. 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. 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. Other Preferred Advanced Degree preferred Experience with front/back-room operations for regulatory inspections Demonstrated leadership and mentoring abilities Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce. 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. The annual compensation range for this full-time position is $100,000 - $120,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.