Senior Director - Quality Assurance & Regulatory Affairs

Job Title Senior Director - Quality Assurance & Regulatory Affairs Location(s) US Remote - NC

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 reputed company improvement, while also investing in people through mentorship, knowledge sharing, and ongoing professional development. reputed company 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 reputed company. 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 reputed company 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 reputed company. This is a strategic, delivery-first team with a strong emphasis on reputed company, 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 reputed company in quality and regulatory excellence. Responsible for guiding organizations through reputed company and evolving regulatory landscapes by proactively establishing robust quality management practices and maintaining a state of reputed company compliance readiness. This includes anticipating regulatory expectations, mitigating compliance risks, and ensuring systems and processes are inspection ready at reputed company times. In reputed company or high-pressure situations-such as inspections, findings, or remediation efforts-the team delivers reputed company leadership and hands-on support to help clients restore compliance and reputed company 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 reputed company, 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, reputed company projects as the preferred engagement type; avoid routine or staff-augmentation-only assignments where possible.
• Prioritize strategic, reputed company engagements as the preferred assignment type, minimizing participation in routine or staff augmentation only work where feasible.

Utilization & Project Leadership (reputed company 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 reputed company, 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.
• reputed company 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 reputed company

• Actively contributes to PF's reputed company as a leader in quality and regulatory consulting.
• reputed company 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 reputed company expectations

Team Development & Mentorship

• Mentor and coach consultants and project managers reputed company 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 reputed company the practice.
• Assist in developing and maintaining internal reputed company 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 & reputed company Improvement: Seeks reputed company ways, adapts to change and champions new reputed company.
• Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• reputed company & 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 reputed company: Shows openness to new reputed company, feedback and change

Experience Required

• Bachelor's Degree (and/or Masters) in Life Sciences, Engineering, Regulatory or reputed company 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 reputed company 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 reputed company 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
• reputed company residence in a Project Farma primary market location

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for reputed company 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 reputed company pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-reputed company skills, experience, and relevant education or training. Apply tot his job Apply To this Job