Raleigh, North Carolina | Remote

Responsibilities

Location Raleigh, North Carolina US Job ID REQ-056978

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)

The Quality Assurance and Regulatory Affairs (QA/RA) Center of Excellence (CoE) is a client‑facing, delivery‑centric practice comprised of senior subject matter experts supporting both internal teams and external clients. Internally, the CoE strengthens Project Farma by developing and sustaining best‑in‑class tools, frameworks, and methodologies that drive consistency, quality, and regulatory alignment. The team proactively monitors regulatory evolution and industry trends, translating insights into actionable guidance and representing the firm through active participation in key professional forums and conferences.

Externally, the QA/RA CoE serves as a trusted advisor, delivering high‑value quality, compliance, and regulatory services across Project Farma’s client portfolio. The practice emphasizes complex, high‑impact engagements over routine or transactional work, providing experienced leadership in quality system development, inspection readiness, remediation, and regulatory strategy. In high‑pressure situations—such as inspections, findings, and recovery efforts—the team delivers hands‑on support to restore compliance, mitigate risk, and achieve sustainable improvements, while advancing business development, thought leadership, and the firm’s market reputation for quality and regulatory excellence.

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.

PerkinElmer 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.