QA/RA Lead Engineer
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Job Description
Lead Engineer providing quality, compliance, and regulatory services across life sciences projects. Mentoring junior engineers and ensuring high delivery standards while managing client relationships.
Responsibilities:
- Serve as a delivery leader on tactical quality and regulatory engagements.
- Ensure delivery excellence, regulatory rigor, and strong client outcomes across all engagements.
- Mentor and guide lower graded individuals.
- Identify opportunities to expand existing engagements into broader or deeper quality and regulatory programs.
- Maintain high billable utilization consistent with senior consulting expectations.
- Travel as required to support client projects, executive workshops, audits, and regulatory-facing activities.
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.
Benefits:
- Health insurance
- Professional development opportunities
- Remote work options
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