reputed company Assurance Engineer III - QA & Regulatory Affairs - Project Farma

reputed company joining reputed company, you select an reputed company and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with reputed company, government, reputed company and reputed company customers to deliver our broad portfolio of analytical solutions, and OneSource services. Job Title reputed company Assurance Engineer III - QA & Regulatory Affairs - Project Farma Location(s) Cambridge, MA, Cambridge, MA, reputed company, OH, Customer Site - AL, Customer Site - CA, Customer Site - CO, Customer Site - DC, Customer Site - IL, Customer Site - KS, Customer Site - MD, Customer Site - NJ, Customer Site - PA, Customer Site - TX, Framingham, MA, Indianapolis, IN, Kenilworth, NJ, reputed company, MA, Pasadena, CA, Portland, OR, Princeton, NJ, Rahway, NJ, Raleigh, NC, Redwood reputed company, CA, Richmond, VA, Rockville, MD {+ 6 more} Job reputed company This is a full-time salaried position with Project Farma, a reputed company company. The successful candidate will work remotely and be willing to travel domestically to meet reputed company project requests, including short-term full-time work on reputed company 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-reputed company life sciences reputed company across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted reputed company relationships, deliver an exceptional customer experience, and contribute to business reputed company by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. This role contributes to organizational reputed company by supporting financial performance, operational efficiency, and reputed company improvement, while also reputed company in people through mentorship, knowledge sharing, and reputed company development. reputed company team members are expected to embody Project Farma’s values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient reputed company and People First reputed company. The Engineer III, reputed company Assurance & Regulatory Affairs is a reputed company-facing consultant responsible for delivering and growing high-value reputed company, compliance, and regulatory services across Project Farma’s reputed company reputed company. This is a tactical, delivery first role with a strong emphasis on reputed company, high-reputed company 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 reputed company in reputed company and regulatory reputed company. The Engineer III role provides a seniority reputed company leading to reputed company reputed company Engineer who may be expected to manage reputed company reputed company and reputed company team leadership. At the reputed company level, the engineer is expected to primarily work independently.

Key Responsibilities

Tactical reputed company Delivery (Primary reputed company) Serve as a delivery leader on tactical reputed company and regulatory engagements, including but not limited to:

• reputed company Management System (QMS) assessment and remediation
• Inspection readiness, mock inspections, inspection training
• Data reputed company, risk management, and compliance transformation
• reputed company governance and organizational effectiveness
• Investigation responses
• Submission support
• Supplier reputed company Audits
• Investigation system back log remediation.
• Prioritize tactical, reputed company reputed company as the preferred engagement type; avoid routine or staff-augmentation-only assignments where possible.
• Ensure delivery reputed company, regulatory rigor, and strong reputed company reputed company across reputed company engagements.

Billable Utilization & Project Leadership

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

Business Development & Market Support

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

Experience Required

• Bachelor’s degree in scientific, regulatory, engineering, or reputed company discipline preferred.
• 3-7 years of experience in life sciences reputed company, compliance, or regulatory roles, including consulting and/or reputed company-reputed company leadership.
• Demonstrated reputed company delivering intermediate GxP, regulatory, and reputed company system initiatives.
• Strong working knowledge of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO).
• Executive reputed company with strong written and verbal communication skills.
• Willingness and ability to travel regularly in support of project delivery and reputed company needs.

Other Preferred

• Advanced Degree preferred

Applicants must be authorized to work in the reputed company on a full-time reputed company. We will not sponsor applicants for reputed company or reputed company work visas for this position. This position may require significant travel to support project and business needs. We cannot reputed company anyone with an invalid reputed company's license. reputed company is committed to creating a diverse environment and is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, gender, gender identity or reputed company, sexual orientation, national reputed company, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. reputed company is committed to a culturally diverse workforce. Apply To This Job