Senior Director - Quality Assurance & Regulatory Affairs

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.

Job Description

Project Farma’s purpose is to improve patient lives by accelerating the delivery of life‑changing therapies. We accomplish this through the successful execution of high‑quality life sciences projects across the full project lifecycle.  Project Farma (PF) team members collaborate with cross‑functional internal teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data‑driven insights to support project planning, cost, schedule, and performance management. This role contributes to organizational success by supporting financial performance, operational efficiency, and continuous improvement, while also investing in people through mentorship, knowledge sharing, and ongoing professional development. All team members are expected to embody Project Farma’s values by being curious, personable, and unselfish, and by consistently demonstrating a strong commitment to a Patient Focused and People First mindset.

Role Summary: Quality Assurance and Regulatory Affairs – Center of Excellence (Practice Area)

Center of Excellence (CoE) personnel serve a dual mandate, supporting both internal teams and external clients. Internally, the CoE strengthens the organization by developing and maintaining best‑in‑class tools, frameworks, and methodologies that ensure consistency, quality, and regulatory alignment. The team tracks evolving regulations, interprets industry trends, and translates insights into actionable guidance while representing the company through active participation in key conferences and professional forums. Externally, CoE personnel act as trusted technical advisors and subject matter experts. CoE team members maintain high billable utilization while contributing to business development, proposals, marketing, and thought leadership, ensuring consistent execution and reinforcing the organization’s reputation as a dependable partner in capital project delivery.

The Quality Assurance and Regulatory Affairs (QA/RA) Center of Excellence (Practice Area) is a group of client-facing subject matter experts responsible for delivering and growing high-value quality, compliance, and regulatory services across Project Farma’s client base. This is a strategic, delivery-first team with a strong emphasis on complex, high-impact engagements rather than routine or transactional work though some staff augmentation work may be performed on larger-scale projects.

The QA/RA team serves as trusted advisors and problem solvers to clients, mentors to consulting staff, and visible contributors to the firm’s market reputation in quality and regulatory excellence.  Responsible for guiding organizations through complex and evolving regulatory landscapes by proactively establishing robust quality management practices and maintaining a state of continuous compliance readiness. This includes anticipating regulatory expectations, mitigating compliance risks, and ensuring systems and processes are inspection ready at all times. In complex or high‑pressure situations—such as inspections, findings, or remediation efforts—the team delivers experienced leadership and hands‑on support to help clients restore compliance and achieve sustainable improvements.

The Senior Director is accountable for shaping strategy, leading leaders, and driving sustained business impact across a significant area of the organization. This role influences enterprise-level decisions, ensures operational excellence, and develops leadership talent while balancing short-term execution with long-term growth objectives.

Key Responsibilities

Strategic Client Delivery (Primary Focus)

• 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.
• Prioritize strategic, complex engagements as the preferred assignment type, minimizing participation in routine or staff augmentation only work where feasible.

Utilization & Project Leadership (All Team Members)

• 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.

Business Development & Market Support

• Support the Quality & Regulatory CoE leaders 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.

Thought Leadership & Market Presence

• Actively contributes 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

Team Development & Mentorship

• 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

Collaboration & Practice Support

• 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 QA/RA CoE Leadership.
• Contribute to firmwide initiatives where quality and regulatory expertise is required.
• Visible thought leadership and market contribution
• Strong balance of delivery excellence and commercial awareness

Attributes for Success

• Technical Delivery: Applies advanced technical knowledge and professional expertise
• Innovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas.
• Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Integrity & Humility: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Collaboration & Communication: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Project Execution: Delivers reliably, manages priorities and drives for high quality outcomes
• Growth Mindset: Shows openness to new ideas, feedback and change

Experience Required

• Bachelor’s Degree (and/or Masters) in Life Sciences, Engineering, Regulatory or related discipline OR a combination of equivalent experience in quality assurance, cGMP facility start-up, regulatory assurance, relevant military and/or professional services.
• Senior Director: minimum 16+ years’ directly relevant experience
• 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.

Other Preferred

• Advanced degree preferred
• Current residence in a Project Farma primary market location

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.

The annual compensation range for this full-time position is $160,000 to $180,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.