Vice President, Quality

The Vice President, Quality is a senior business leader accountable for the strategy, growth, financial performance, and delivery excellence of Syner-G’s Quality practice. Reporting to the EVP, Head of Product Development, this leader will build and scale a differentiated GxP Quality practice that supports biotechnology and pharmaceutical companies across the product development lifecycle.

This role leads the Quality organization, including senior Quality team members and functional leaders, and is responsible for practice P&L performance. The Vice President, Quality will establish long-term strategy, expand service offerings and capabilities, drive business development activities, and ensure consistent delivery of high-quality client solutions. Success in this role requires deep GxP expertise, strong commercial acumen, and the ability to effectively navigate executive leadership, client engagement, technical quality challenges, and financial management.

Key Responsibilities:

Business Leadership & Practice Growth

• Own the Quality practice P&L, including revenue, gross margin, utilization, forecasting, backlog management, and hiring.
• Establish annual and long-term growth objectives and strategic priorities for the Quality business.
• Translate client demand, pipeline activity, and backlog into effective staffing and resource plans.
• Monitor business performance and implement strategies to improve growth, profitability, utilization, and delivery outcomes.
• Build and scale a high-performing organization that supports profitable growth, technical excellence, and outstanding client service.
• Partner with Product Development, Finance, Business Development, and other key stakeholders on forecasting and investment decisions.

Strategy & Service Development

• Develop and execute the Quality practice’s long-term growth strategy.
• Build differentiated service offerings that support emerging, clinical-stage, and commercial biotechnology and pharmaceutical companies.
• Develop scalable engagement models ranging from targeted consulting support to fully outsourced Quality functions.
• Establish repeatable methodologies, tools, templates, and delivery frameworks to improve quality, efficiency, and profitability.

GxP Quality Leadership

• Provide strategic leadership across GMP, GCP, GLP, and Quality Management Systems, ensuring phase-appropriate quality strategies and organizational design.
• Oversee SOP management, deviations, investigations, CAPA, change control, and Quality Risk Management activities.
• Lead supplier qualification programs, CDMO and CRO oversight, internal audits, and external audit readiness.
• Support regulatory inspections, inspection readiness activities, clinical quality programs, and data integrity initiatives.
• Develop training programs, quality metrics, management review processes, and commercial readiness strategies.
• Serve as Head of Quality for select clients through direct or fractional leadership engagements.

Client Engagement & Delivery Excellence

• Serve as a trusted advisor to executive leadership teams, boards, and quality organizations across client companies.
• Develop pragmatic, risk-based quality strategies aligned with business and product development goals.
• Provide executive oversight for strategic and complex client engagements.
• Establish consistent standards for technical quality, project execution, communication, documentation, and client service.
• Identify and mitigate delivery, financial, scope, and client relationship risks to ensure successful outcomes.

Business Development & Market Presence

• Partner with Business Development to expand Quality services and cultivate client relationships.
• Participate in strategic sales discussions, proposals, capability presentations, and executive-level meetings.
• Translate client needs into defined scopes of work, staffing models, deliverables, and commercial proposals.
• Expand Quality service opportunities within existing Product Development, Regulatory, Clinical, CMC, and Nonclinical engagements.
• Develop strategic partnerships with complementary quality organizations and specialized service providers.
• Enhance Syner-G’s market presence through industry engagement, publications, speaking opportunities, and thought leadership.

Talent & Organizational Leadership

• Lead, mentor, and develop senior Quality leaders and team members.
• Establish organizational structure, accountability, decision-making frameworks, and career progression pathways.
• Recruit, develop, and retain high-performing Quality professionals while building leadership succession plans.
• Leverage the Syner-G Quality career ladder to support employee development and advancement.
• Foster a culture focused on technical excellence, collaboration, accountability, responsiveness, and commercial awareness.

Cross-Functional Product Development Leadership

• Ensure Quality operates as an integrated component of the Product Development organization.
• Partner closely with Regulatory, CMC, Nonclinical, Clinical Supplies, Program Management, and other disciplines to support development programs from early-stage development through commercialization.
• Guide clients in understanding how quality decisions impact development timelines, manufacturing readiness, regulatory strategy, clinical execution, and commercialization efforts.