Senior Consultant - MedTech QMS

Lever, Inc.; Boston (MA); Remote; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision, and basiclife

Flexible PTO and company holidays

Retirement programs

1% charitable giving program

Job summary

Veeva Systems is a mission-driven organization enabling life sciences leaders to transform how they bring therapies to patients. The MedTech Quality consultant will drive QMS implementations globally, partner with Professional Services, and guide customers in adopting Vault and best practices for post-implementation success.

The role requires 6+ years in GMP systems or software consulting, deep regulatory knowledge (FDA/EU MDR/IVDR), and strong communication in a fast-paced SaaS environment.

Qualifications

• 6+ years of experience in GMP Systems ownership or Software Consulting.
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting.
• Understanding of Complaint Handling, CAPA, Nonconformance and Risk Management.
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11.

Responsibilities

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions
• Function as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd parties
• Analyze customer requirements and new product features to develop customer adoption and enhancement roadmaps
• Guide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customer

Skills

GMP Systems ownership

Software Consulting

Regulatory knowledge (FDA/EU MDR)

Quality Management / QMS experience

Life Sciences domain

Excellent communication

Veeva Vault

Tools

Veeva Vault

Job description

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

Veeva is looking for an experienced quality software consultant to lead implementations at Veeva’s MedTech customers globally. This role will guide the transformation of our customers’ Quality Management processes and technology. The MedTech Quality consultant will work closely with Professional Services teams to ensure delivery success across QMS implementations.

What You’ll Do

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions
• Function as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd parties
• Analyze customer requirements and new product features to develop customer adoption and enhancement roadmaps
• Guide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customer

Requirements

• 6+ years of experience in GMP Systems ownership or Software Consulting
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting
• Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11
• Ability to understand business requirements and design creative solutions
• Excellent verbal and written communication skills
• Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces

Nice to Have

• Veeva Vault implementation experience
• Management Consulting
• Change Management experience
• Field Action and Product Return experience
• Complaints Management for Medical Device preferred

Perks & Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program

Compensation

• Base pay: $80,000 - $200,000
• The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [e-mail].