6343 - Quality Lead / Quality Engineer

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

This position will be responsible for supporting the Quality Information Systems Management (QISM) group, working closely with operational functions and other business and QA groups to facilitate regulatory/data integrity assessments, change control review requirements gathering, design, and system validation. This role will perform quality oversight functions and take quality ownership for all related computerized system projects with particular focus on Manufacturing and Analytical Laboratory systems., * Proficient with Computerized systems on the Enterprise Level, ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data analytics platforms, Manufacturing Systems, and Lab Systems and provide Quality oversight on the related system projects.

• Take Quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for the projects that include New implementation, Enhancements, Quarterly releases, Periodic reviews, review and approve Quality events (deviations & CAPS), etc.
• Participate and Drive System Assessments, review and approve the project deliverables, including plan, test scripts, execution and its outcome, reports, and traceability.
• Participate and drive the discussions on issues to the resolutions, adhering to quality compliance.
• Sound knowledge of and Embrace Data Integrity integral to the system projects.
• Should possess good communication skills and fit well as a team player.
• Highlight any identified quality risks and present possible mitigation options to the project team, and keep informed of the quality management.
• Perform, evaluate, and communicate thorough quality assurance at every stage of systems development/implementation

Do you have experience in Technical writing?, Do you have a Bachelor’s degree?, * Bachelor’s degree in IT or Computer Science

• 6-10+ years of proven experience in computerized systems, Enterprise Level and Lab systems validation/quality capacity
• Familiarization with ITIL/GAMP5 Validation Lifecycle
• Proven analytical abilities
• Practical experience generating process documentation and reports
• Excellent communicator with the ability to translate data into actionable insights
• Hybrid role: 3 days/week onsite in South Boston/Seaport location, * Strong working knowledge of relevant computerized systems module, structure design
• Proven capabilities in project and user-testing management
• Proven development of innovative and impactful systems solutions
• Highly proficient technical writing capabilities
• Knowledge of Agile validation lifecycle and methodologies.
• Experience with Veeva VQMS, ServiceNow and Application Lifecycle Management with e-signature (ALM) system is highly desirable.

3.63.6 out of 5 stars Boston, MA Hybrid work $87,780 - $136,225 a year, Pulled from the full job description

• Referral program
• Tuition reimbursement
• Paid parental leave
• Parental leave
• Health insurance
• 401(k) matching
• Paid time off, Why Choose Verista?
• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.