QA/RA Senior Director - Project Farma

This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will reside in one of Project Farma's primary markets and be willing to travel domestically to meet client project requests.   

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 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 professional development. 

All team members are expected to embody Project Farma’s values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset. 

The Director QA/RA is a responsible for supporting project execution through technical contribution, analysis, and problem-solving with limited guidance. May serve as project QA/RA lead or project lead / manager. This role applies intermediate to advanced technical expertise on more than one subject to solve complex problems, contributes meaningfully to project outcomes, and demonstrates increased independence in executing assigned work. Directors are expected to build foundational skills, apply Project Farma methodologies, and deliver high-quality work products while collaborating across disciplines. This role requires sound judgment, effective prioritization, within established project frameworks, and continued growth toward greater ownership and technical proficiency.  

The Director / Senior Director is responsible for leading a project team and overseeing the execution of work aligned to project, client, and business objectives. This role balances people leadership with operational accountability, including coaching, performance management, resource planning, and ensuring high-quality delivery within defined scope, timelines, and budget. 

Key Responsibilities 

The Senior Director RA/QA is a strategic and technical leader with deep experience across multiple areas of expertise who serves as a subject-matter expert and drives complex workstreams from planning through execution. Senior Directors independently lead project workstreams, proactively identify risks and improvement opportunities, and ensure alignment with client and business expectations. They act as trusted advisors to project teams and stakeholders while demonstrating leadership through mentorship, quality ownership, and cross-functional collaborations. This role requires strategic problem-solving, sound judgement, and a high level of accountability in driving results.  

The Senior Director provides experienced people leadership and operational oversight across multiple projects or functional areas. This role is accountable for team performance, talent development, and consistent execution of business priorities, while partnering with senior leaders to drive continuous improvement, scalability, and organizational effectiveness. 

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 

• Develop and deliver training and workshops 

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. 

Billable Utilization & Project Leadership 

• 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 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. 

Thought Leadership & Market Presence 

• 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 

Team Development & Mentorship 

• Mentor and coach consultants and project Directors 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 

Internal 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 VP, Quality & Regulatory Services. 

• Contribute to firmwide initiatives where quality and regulatory expertise is required. 

Experience Required 

• 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, 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 in development and presentation of thought leadership including conference presentations, white papers, published papers, etc. 

• Willingness to travel as required for client project assignments. 

Other Preferred  

• Advanced Degree preferred  

• One or more industry-specific certifications