5903 - Senior Quality Lead / Senior Quality Lead
Location: Boston, MA (Hybrid)
Department: CSV CSA Enterprise
Description
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.
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
Senior Quality Lead Job Responsibilities:
- Lead comprehensive gap assessments of IT/Digital Technology systems not formally evaluated under current GxP Criticality Assessment procedures, identifying compliance risks and areas requiring remediation
- Develop, own, and execute remediation plans, driving cross-functional alignment to ensure timely and compliant resolution of identified gaps
- Manage and track remediation activities, including milestones, documentation, and objective evidence, through to formal closure
- Author and maintain required quality documentation, including gap assessments, remediation plans, deviations, CAPAs, change controls, and qualification deliverables
- Partner cross-functionally with Quality, IT/DTE, Infrastructure, Validation, Information Security, and Business stakeholders to ensure alignment with regulatory expectations and internal standards
- Drive continuous improvement by revising and enhancing SOPs and Work Instructions based on remediation outcomes, emerging regulatory requirements, and identified process gaps
Job Requirements:
- Bachelor’s degree in Life Sciences, Information Systems, Quality, Engineering, or a related discipline
- 7+ years of experience working in GxP-regulated environments with strong knowledge of applicable regulations (e.g., 21 CFR Part 11, Annex 11, data integrity principles)
- Experience in pharmaceutical or biotechnology settings, with exposure to Infrastructure Qualification, CSV, or CSA methodologies preferred
- Proficiency in documentation practices and quality systems, including experience with IT Service Management tools (e.g., ServiceNow) and Quality Management Systems
- Strong regulatory and quality mindset with risk-based thinking, cross-functional collaboration skills, and a focus on inspection readiness and Good Documentation Practices (GDP)
- Ability to be on-site, part-time in South Boston, MA (Seaport area). 3 days per week on-site at a minimum.
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
Benefits
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 collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
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