About the Opportunity
We are seeking an accomplished VP Quality Management to join a global biotechnology organization committed to delivering innovative therapies that improve patient outcomes worldwide. As a key member of the executive leadership team, the Vice President of Quality Management will establish the strategic vision for enterprise quality programs while ensuring the highest standards of product quality, regulatory compliance, operational excellence, and continuous improvement across global manufacturing and commercial operations.
This executive leadership role oversees all aspects of quality management, including Quality Assurance, Quality Control, Supplier Quality, Validation, Compliance, Audit Readiness, Risk Management, and Quality Systems. The VP Quality Management will collaborate closely with Manufacturing, Regulatory Affairs, Research & Development, Engineering, Supply Chain, Clinical Operations, and Executive Leadership to ensure organizational processes consistently meet global regulatory requirements and industry best practices.
The successful candidate will possess extensive executive leadership experience within highly regulated pharmaceutical, biotechnology, medical device, or life sciences organizations. This individual will be responsible for building a culture of quality, strengthening enterprise-wide quality systems, leading global inspection readiness initiatives, and driving strategic improvements that support long-term organizational growth.
This is a unique opportunity to influence executive decision-making, strengthen global quality operations, and lead transformational initiatives within one of the industry’s most innovative organizations.
Essential Duties and Responsibilities
- Develop and execute the organization’s global quality management strategy aligned with corporate objectives and regulatory requirements.
- Provide executive leadership for Quality Assurance, Quality Control, Supplier Quality, Validation, Compliance, and Quality Systems functions.
- Establish enterprise quality standards that support manufacturing excellence, product integrity, and regulatory compliance.
- Lead global inspection readiness programs supporting FDA, EMA, MHRA, Health Canada, and other international regulatory agencies.
- Oversee implementation and continuous improvement of Quality Management Systems (QMS) across global operations.
- Direct enterprise CAPA, deviation management, change control, risk management, document control, and audit programs.
- Collaborate with Manufacturing and Engineering to improve process capability, operational efficiency, and product quality.
- Develop quality metrics, executive dashboards, and performance indicators that support strategic decision-making.
- Lead internal audits, supplier quality programs, and external regulatory inspections.
- Partner with Regulatory Affairs to ensure successful product approvals and ongoing regulatory compliance.
- Drive quality culture initiatives through leadership development, employee engagement, and continuous improvement programs.
- Evaluate emerging regulatory trends and implement proactive compliance strategies.
- Manage quality budgets, organizational planning, resource allocation, and succession planning.
- Build strategic relationships with regulatory authorities, executive stakeholders, and external partners.
- Support mergers, acquisitions, technology transfers, and new facility integration activities.
- Present quality performance, compliance initiatives, and strategic recommendations to Executive Leadership and the Board of Directors.
Job Qualifications and Requirements
- Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related technical discipline.
- Master’s degree or Ph.D. preferred.
- Minimum 15 years of progressive leadership experience in Quality Management within biotechnology, pharmaceuticals, medical devices, or life sciences.
- Minimum 8 years in senior executive or vice president-level leadership positions.
- Comprehensive knowledge of FDA, EMA, ICH, ISO, GMP, GLP, GCP, and international regulatory standards.
- Proven experience leading enterprise Quality Management Systems across global operations.
- Demonstrated success managing regulatory inspections and executive-level quality initiatives.
- Strong expertise in Quality Assurance, Quality Control, Validation, Supplier Quality, Risk Management, and Compliance.
- Experience supporting commercial manufacturing, clinical operations, and product commercialization.
- Strong financial planning, organizational leadership, and executive management capabilities.
- Outstanding communication, executive presentation, and stakeholder management skills.
- Professional certifications such as ASQ CQE, CQA, CMQ/OE, or equivalent are highly desirable.
Personal Capabilities and Qualifications
- Visionary executive leadership with exceptional strategic planning abilities.
- Strong regulatory and quality management expertise.
- Outstanding executive communication and leadership presence.
- Analytical decision-maker with excellent business judgment.
- Proven ability to lead large global organizations through organizational transformation.
- Collaborative leadership style with strong cross-functional influence.
- Exceptional problem-solving and risk management capabilities.
- Strong coaching and executive talent development experience.
- High ethical standards, integrity, and accountability.
- Commitment to operational excellence and continuous improvement.
- Ability to manage complex global initiatives within highly regulated environments.
Strategic Support
The VP Quality Management serves as a strategic executive leader responsible for ensuring quality remains a foundational element of the organization’s global operations. This role partners closely with Executive Leadership, Manufacturing, Regulatory Affairs, Engineering, Supply Chain, Clinical Operations, Finance, and Research & Development to strengthen quality systems, improve regulatory compliance, mitigate organizational risk, and support sustainable business growth.
Through enterprise-wide quality initiatives, operational excellence programs, and continuous improvement strategies, this position directly influences corporate performance, customer confidence, regulatory success, and long-term organizational competitiveness.
Working Conditions
- Hybrid executive leadership position based in Boston, Massachusetts.
- Periodic domestic and international travel to manufacturing sites, global offices, regulatory agencies, and industry conferences.
- Frequent interaction with executive leadership, regulatory authorities, manufacturing teams, and global business partners.
- Fast-paced, highly regulated biotechnology environment requiring executive decision-making.
- Occasional extended hours during inspections, audits, product launches, and strategic initiatives.
- Company-provided executive technology and collaboration resources.
Job Function
The VP Quality Management provides executive leadership for the organization’s global quality strategy by overseeing quality assurance, quality control, compliance, validation, regulatory readiness, supplier quality, and enterprise quality systems. This role ensures products, processes, and operations consistently meet the highest standards of quality, safety, and regulatory compliance while supporting innovation, operational excellence, and long-term business growth.
Compensation & Benefits
Compensation Package: $390,000 – $450,000 annually, based on executive leadership experience, global operational scope, industry expertise, and overall qualifications. Total compensation may include a competitive base salary, an annual executive performance bonus, long-term incentive plans, and equity awards.
Our comprehensive executive benefits package includes:
- Executive annual performance bonus
- Long-term equity incentive program
- Comprehensive medical, dental, and vision insurance
- 401(k) retirement plan with generous company matching
- Executive retirement planning resources
- Flexible paid time off and executive wellness days
- Paid parental and family leave
- Executive health and wellness program
- Tuition reimbursement and executive education assistance
- Leadership coaching and professional development
- Employee stock purchase plan (where applicable)
- Health Savings Account (HSA) and Flexible Spending Account (FSA)
- Life, AD&D, and long-term disability insurance
- Employee Assistance Program (EAP)
- Relocation assistance (where applicable)
- Company-sponsored executive leadership summits
- Career advancement within a global biotechnology organization
Why Join Us
Joining our organization means becoming part of a globally respected biotechnology company dedicated to improving lives through scientific innovation and uncompromising quality. We believe quality is more than a function; it is a strategic advantage that drives customer trust, regulatory excellence, and long-term business success.
As VP Quality Management, you will influence enterprise-wide strategy, lead transformational quality initiatives, and help shape the future of a global organization committed to operational excellence. If you are an accomplished executive leader passionate about advancing quality, strengthening compliance, and building high-performing teams, we invite you to join us and make a lasting impact on the future of healthcare.
Job Features
| Job Category | Biotechnology & Pharmaceutical Manufacturing |