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For 85 years, we have pushed the boundaries of science with a clear purpose – to help our customers achieve theirs.
QA/RA Director
Location
North Carolina
Posted
13 days ago
Salary
$165K - $200K / year
Seniority
Lead
Job Description
QA/RA Director
PerkinElmer
• Serve as a senior advisor and delivery leader on strategic quality and regulatory engagements • Design and remediate Quality Management Systems (QMS) • Conduct inspection readiness and mock inspections • Provide regulatory responses and training • Manage data integrity, risk management, and compliance transformation • Oversee investigation responses and submission support • Lead supplier quality audits and new product introduction development • Mentor and coach consultants and project Directors within Quality & Regulatory practice • Collaborate with internal teams for resource alignment and strategy planning
Job Requirements
- Bachelor’s degree in scientific, regulatory, engineering, or related discipline preferred
- 16 years (Director) – 20 years (Sr. Director) of experience in life sciences quality, compliance, or regulatory roles
- Demonstrated success delivering and advising on complex GxP, regulatory, and quality system initiatives
- Strong working knowledge of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO)
- Proven ability to support sales and business development in a consulting environment
- Executive presence with strong written and verbal communication skills
- Willingness and ability to travel regularly in support of project delivery and client needs
- Previous experience in development and presentation of thought leadership including conference presentations, white papers, published papers, etc.
- Advanced Degree preferred
- One or more industry-specific certifications
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
- Travel allowances
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