Vice President, Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of the Quality practice's P&L, which includes revenue, gross margin, utilization, forecasting, backlog management, and recruitment.

• Set annual and long-term growth targets along with strategic priorities.

• Convert client demand, pipeline activities, and backlog into staffing and resource plans.

• Track performance and enhance growth, profitability, utilization, and delivery results.

• Develop and expand a high-performing Quality organization.

• Collaborate with Product Development, Finance, Business Development, and stakeholders for forecasting and investment decisions.

• Create and implement the long-term growth strategy for the Quality practice.

• Develop unique service offerings and scalable engagement models.

• Establish methodologies, tools, templates, and delivery frameworks.

• Lead activities related to GMP, GCP, GLP, and Quality Management Systems.

• Oversee SOP management, deviations, investigations, CAPA, change control, and Quality Risk Management.

• Direct supplier qualification, CDMO/CRO oversight, internal audits, and external audit readiness.

• Assist with regulatory inspections, inspection readiness, clinical quality programs, and data integrity initiatives.

• Create training programs, quality metrics, management review processes, and commercial readiness strategies.

• Serve as Head of Quality for specific clients.

• Provide guidance to executive leadership teams, boards, and client quality organizations.

• Offer executive oversight for strategic and complex engagements.

• Manage technical quality, project execution, documentation, client service, and delivery risks.

• Collaborate with Business Development on sales discussions, proposals, capability presentations, and commercial proposals.

• Cultivate strategic partnerships and strengthen Syner-G’s market presence.

• Lead, mentor, develop, recruit, and retain senior Quality professionals.

• Establish organizational structures, accountability frameworks, decision-making processes, and career pathways.

• Integrate Quality with Regulatory, CMC, Nonclinical, Clinical Supplies, and Program Management throughout product development to commercialization.

⛳️ Requirements

• A Bachelor's degree in a scientific, engineering, life sciences, or related field is required.

• Over 15 years of progressively responsible experience in pharmaceutical, biotechnology, or life sciences Quality organizations.

• Significant leadership experience in managing and developing GxP Quality functions.

• Experience in supporting products from early clinical development to commercialization.

• Proven success in building, scaling, or transforming Quality organizations and Quality Management Systems.

• Demonstrated ability to lead multidisciplinary teams and develop technical talent.

• Strong knowledge of FDA, EMA, ICH, and global GxP regulations, guidance, and industry expectations.

• In-depth understanding of Quality Management Systems and phase-appropriate Quality strategies.

• Excellent leadership, coaching, team development, and organizational management skills.

• Capability to develop and execute business strategies that foster growth, operational excellence, and client success.

• Strong financial and business acumen, including performance metrics, resource forecasting, and organizational growth.

• Exceptional skills in client-facing, relationship management, and stakeholder engagement.

• Excellent verbal and written communication, presentation, and executive influencing abilities.

• Proficient in navigating complex technical, operational, and commercial challenges while making pragmatic, risk-based decisions.

• Strong cross-functional collaboration skills.

• Current work authorization is required upon acceptance of the position.

• Syner-G cannot sponsor or take over sponsorship of an employment visa.

🏝️ Benefits

• Competitive base salary in the market.

• Annual incentive plan.

• Comprehensive benefit offerings.

• Generous flexible paid time off program.

• Company-paid holidays.

• Flexible working hours.

• Primarily remote work options for most roles.

• Opportunity to work “almost anywhere.”

• Continuous recognition and career development opportunities.

• Supportive company culture.

• Office locations available in Greater Boston, San Diego, Boulder, and India.