What are the responsibilities and job description for the Quality Assurance Engineer III - QA & Regulatory Affairs - Project Farma position at PerkinElmer?
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 Engineer III, Quality Assurance & Regulatory Affairs 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 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:
This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.
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 Engineer III, Quality Assurance & Regulatory Affairs 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 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.
- 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.
- 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.
- Advanced Degree preferred
This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.