COMPANY DESCRIPTION:
A career here is life-enhancing.
At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit www.Synergbiopharma.com
POSITION OVERVIEW:
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:
(This list is not exhaustive and may be supplemented and changed as necessary.)
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.
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Education
- Bachelor's degree in a scientific, engineering, life sciences, or related discipline required.
- Advanced degree (e.g., MS, MBA, PhD, or equivalent) preferred.
Experience
- 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 across multiple stages of development, 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.
- Experience with financial management, resource planning, forecasting, and P&L responsibility preferred.
- Consulting or professional services experience preferred.
- Recognized industry presence through publications, conference presentations, health authority experience, or other thought leadership activities preferred.
Knowledge, Skills & Abilities
- 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 within pharmaceutical and biotechnology environments.
- Strong leadership, coaching, team development, and organizational management skills.
- Demonstrated ability to develop and execute business strategies that support growth, operational excellence, and client success.
- Strong financial and business acumen with the ability to evaluate performance metrics, forecast resource needs, and support 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 decision-making.
- Strong collaboration skills with the ability to work effectively across cross-functional teams and organizational levels.
ESSENTIAL FUNCTIONS:
Physical Demands:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
TOTAL REWARDS PROGRAM:
We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
LEGAL STATEMENT:
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.
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