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Quality Assurance Director
PerkinElmer. Serve as a senior advisor and delivery leader on strategic quality and regulatory engagements .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in quality management systems, regulatory compliance, and strategic project leadership within the life sciences sector. Proven ability to mentor teams, develop thought leadership, and drive client engagement through effective communication and business development.
Highest-signal resume keywords
Quality Management System DesignRegulatory Compliance ExpertiseGlobal Regulatory Frameworks KnowledgeBusiness Development SupportThought Leadership Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality GovernanceRisk ManagementData IntegrityRegulatory StrategyGxP InitiativesInspection ReadinessSupplier Quality AuditsNew Product IntroductionRegulatory ResponsesComplex Project Delivery
Soft Skills
Executive PresenceWritten CommunicationVerbal CommunicationMentoringCoaching
Certifications & Qualifications
Industry-Specific Certifications
Industry Keywords
Life SciencesFDAEMAMHRAICHWHOCompliance TransformationClient EngagementProposal DevelopmentTalent Development
About the role
Key responsibilities & impact- Serve as a senior advisor and delivery leader on strategic quality and regulatory engagements
- Lead Quality Management System design and remediation, inspection readiness, regulatory responses, data integrity, risk management, compliance transformation, quality governance, investigations, submission support, supplier quality audits, new product introduction, and regulatory strategy engagements
- Develop and deliver training and workshops
- Prioritize complex strategic projects and ensure delivery excellence, regulatory rigor, and strong client outcomes
- Maintain high billable utilization and travel for client projects, executive workshops, audits, and regulatory-facing activities
- Act as project sponsor or senior engagement lead, guiding scope, approach, and client communication
- Support sales, business development, proposal development, scope definition, pricing input, and client presentations
- Identify opportunities to expand existing engagements
- Develop thought leadership including white papers, frameworks, case studies, and internal methodologies
- Represent Project Farma at industry forums, conferences, webinars, and professional societies
- Monitor US, EMA, and ROW regulatory changes and expectations
- Mentor and coach consultants and project Directors
- Provide technical and professional guidance and support talent development
- Collaborate with Regional VPs, Client Engagement, and Client Solutions teams
- Support practice planning, capability development, and service-line evolution
- Contribute to firmwide initiatives requiring quality and regulatory expertise
Requirements
What you’ll need- Bachelor’s degree in scientific, regulatory, engineering, or related discipline preferred
- 16 years of experience for Director, or 20 years for Sr. Director, in life sciences quality, compliance, or regulatory roles, including consulting and/or owner-side leadership
- 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 developing and presenting thought leadership, including conference presentations, white papers, published papers, etc.
- Advanced degree preferred
- One or more industry-specific certifications
- Must be authorized to work in the United States on a full-time basis
- No current or future work visa sponsorship
- Cannot be employed with an invalid driver's license
Benefits
Comp & perks- Full-time salaried position
- Professional development
- Mentorship and knowledge sharing
- Diverse and equal-opportunity work environment