QA/RA Director
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Job Description
Provides strategic quality and regulatory compliance leadership at Project Farma in high-impact life sciences projects. Mentoring consultants and managing client engagements with a focus on quality systems.
Responsibilities:
- 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
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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