Senior Consultant - MedTech QMS Complaints
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 $2B 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 apublic benefit corporation(PBC), legally bound to balancing the interests of customers, employees, society, and investors.As aWork Anywherecompany, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.Join us intransforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.The RoleVeeva is looking for an experienced consultant to lead MedTech Complaints implementations at Veeva’s MedTechcustomers globally. This role will guide the transformation of our customers’ Complaints Management processes and technology. The MedTech Complaints 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 Complaints 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
8+ years of experience in Project Management, GMP Systems ownership, or Software Consulting
4+ years of experience in Complaints Management for Medical Device
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
Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsor
Proven ability to work both independently and in teams in a dynamic, fast-moving environment
Good understanding of SaaS and GxP principles
Ability to quickly understand business requirements and design creative solutions
Excellent verbal and written communication skills
Experience in the Lifesciences Quality, Manufacturing, or Healthcare spaces
Experience with Data or Content Management applications Nice to Have
Veeva Vault implementation experience
Management Consulting
Change Management experience
Field Action and Product Return experience
Clinical Medical Device, Biologics, and SaMD experience 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. Additional Information
#LI-RemoteUS
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 [email protected].
Apply Now
Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
Lead QMS Complaints 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
8+ years of experience in Project Management, GMP Systems ownership, or Software Consulting
4+ years of experience in Complaints Management for Medical Device
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
Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsor
Proven ability to work both independently and in teams in a dynamic, fast-moving environment
Good understanding of SaaS and GxP principles
Ability to quickly understand business requirements and design creative solutions
Excellent verbal and written communication skills
Experience in the Lifesciences Quality, Manufacturing, or Healthcare spaces
Experience with Data or Content Management applications Nice to Have
Veeva Vault implementation experience
Management Consulting
Change Management experience
Field Action and Product Return experience
Clinical Medical Device, Biologics, and SaMD experience 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. Additional Information
#LI-RemoteUS
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 [email protected].
Apply Now