Director, Quality & Regulatory Assurance
About The Position
When joining PerkinElmer, you select an experienced 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 commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services. The Director, Quality & Regulatory Assurance (Senior Practice SME) is a senior, client-facing consulting leader responsible for delivering and growing high-value quality, compliance, and regulatory services across Project Farma’s client base. This is a strategic, delivery first role with a strong emphasis on complex, high-impact 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, proposal development and defense, marketing, and industry thought leadership. The Associate Practice Leader serves as a trusted advisor and problem solver to clients, a mentor to consulting staff, and a visible contributor to the firm’s market reputation in quality and regulatory excellence.
Requirements
- Bachelor’s degree in scientific, regulatory, engineering, or related discipline preferred.
- 15+ years of experience 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.
Responsibilities
- Serve as a senior advisor and delivery leader on strategic quality and regulatory engagements, including but not limited to: Quality Management System (QMS) design and remediation Inspection readiness, mock inspections, inspection training Regulatory responses Data integrity, risk management, and compliance transformation Quality governance and organizational effectiveness Investigation responses Submission support, FDA facing meeting support Supplier Quality Audits New Product Introduction development and management Investigation system development and remediation Quality Management Maturity Model assessment and remediation Regulatory Strategy
- Prioritize strategic, complex projects as the preferred engagement type; avoid routine or staff-augmentation-only assignments where possible.
- Ensure delivery excellence, regulatory rigor, and strong client outcomes across all engagements.
- Maintain high billable utilization consistent with senior consulting expectations.
- Travel as required to support client projects, executive workshops, audits, and regulatory-facing activities.
- Act as project sponsor or senior engagement lead, guiding scope, approach, and client communication.
- Support the VP, Quality & Regulatory Services and commercial teams in selling quality, compliance, and regulatory services.
- Lead or contribute to proposal development, scope definition, pricing input, and client presentations.
- Identify opportunities to expand existing engagements into broader or deeper quality and regulatory programs.
- Actively contribute to PF’s reputation as a leader in quality and regulatory consulting.
- Develop intellectual capital such as white papers, frameworks, case studies, and internal methodologies.
- Represent the firm at industry forums, conferences, webinars, and professional societies (e.g., ISPE, PDA, ASQ, RAPS).
- Remain at the forefront of US, EMA, and ROW regulatory changes and current expectations
- Mentor and coach consultants and project managers within the Quality & Regulatory practice and across the entire organization.
- Provide technical and professional guidance to ensure consistent delivery quality and consultant development.
- Support talent development and capability-building initiatives within the practice.
- Assist in developing and maintaining internal knowledge management subject
- Collaborate with Regional VPs, Client Engagement, and Client Solutions teams to align resources with strategic client needs.
- Support practice planning, capability development, and service-line evolution under the direction of the VP, Quality & Regulatory Services.
- Contribute to firmwide initiatives where quality and regulatory expertise is required.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
