Vice President, Quality

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Vice President

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• 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 • Translate client demand, pipeline activity, and backlog into staffing and resource plans • Monitor performance and improve growth, profitability, utilization, and delivery outcomes • Build and scale a high-performing Quality organization • Partner with Product Development, Finance, Business Development, and stakeholders on forecasting and investment decisions • Develop and execute the Quality practice’s long-term growth strategy • Build differentiated service offerings and scalable engagement models • Establish methodologies, tools, templates, and delivery frameworks • Lead GMP, GCP, GLP, and Quality Management Systems activities • Oversee SOP management, deviations, investigations, CAPA, change control, and Quality Risk Management • Lead supplier qualification, CDMO/CRO oversight, internal audits, and external audit readiness • Support regulatory inspections, inspection readiness, 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 • Advise executive leadership teams, boards, and client quality organizations • Provide executive oversight for strategic and complex engagements • Manage technical quality, project execution, documentation, client service, and delivery risks • Partner with Business Development on sales discussions, proposals, capability presentations, and commercial proposals • Develop strategic partnerships and enhance 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 across product development through commercialization

🎯 Requirements

• Bachelor's degree in a scientific, engineering, life sciences, or related discipline required • 15+ years of progressive experience within pharmaceutical, biotechnology, or life sciences Quality organizations • Significant leadership experience managing and developing GxP Quality functions • Experience supporting products from early clinical development through commercialization • Demonstrated success building, scaling, or transforming Quality organizations and Quality Management Systems • Proven experience leading multidisciplinary teams and developing technical talent • Strong knowledge of FDA, EMA, ICH, and global GxP regulations, guidance, and industry expectations • Deep understanding of Quality Management Systems and phase-appropriate Quality strategies • Strong leadership, coaching, team development, and organizational management skills • Ability to develop and execute business strategies supporting growth, operational excellence, and client success • Strong financial and business acumen, including performance metrics, resource forecasting, and organizational growth • Exceptional client-facing, relationship management, and stakeholder engagement skills • Excellent verbal and written communication, presentation, and executive influencing skills • Ability to navigate complex technical, operational, and commercial challenges and drive pragmatic, risk-based decisions • Strong cross-functional collaboration skills • Current work authorization required when accepting a position • Syner-G is unable to sponsor or take over sponsorship of an employment visa

🏖️ Benefits

• Market competitive base salary • Annual incentive plan • Robust benefit offerings • Generous flexible paid time off program • Company paid holidays • Flexible working hours • Fully remote work options for most positions • Ability to work “almost anywhere” • Ongoing recognition and career development opportunities • Supportive culture • Office locations available in Greater Boston, San Diego, Boulder, and India

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