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Quality Assurance Engineer III - QA & Regulatory Affairs - Project FarmaPerkinElmer • Austin, Texas, United States
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Quality Assurance Engineer III - QA & Regulatory Affairs - Project Farma

PerkinElmer
  • US
    Austin, Texas, United States
  • US
    Austin, Texas, United States
Postuler Maintenant

À propos

Quality Assurance Engineer III - QA & Regulatory Affairs - Project Farma Austin, Texas | Annapolis, Maryland | Cambridge, Massachusetts | Columbus, Ohio | Denver, Colorado | Framingham, Massachusetts | Indianapolis, Indiana | Kenilworth, New Jersey | Montgomery, Alabama | Norwood, Massachusetts | Pasadena, California
Responsibilities Location: Austin, Texas US
Job ID: REQ-057356
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. 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
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
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.
Equal Opportunity PerkinElmer 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.
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  • Austin, Texas, United States

Compétences linguistiques

  • English
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