Quality Assurance Lead

4 weeks ago


Boston, Massachusetts, United States Verista Full time
Job Title: Quality Lead/ Lead Validation Engineer

Verista is a leading provider of innovative solutions and services to the life science industry. We empower growth and innovation within the scientific community, helping researchers, organizations, and companies solve some of the world's most pressing healthcare challenges.

As a Quality Lead/ Lead Validation Engineer at Verista, you will play a critical role in ensuring the quality and integrity of our computerized systems. You will work closely with our QISM group, IT Infrastructure, and Clinical Operations teams to provide oversight of system implementation, maintenance, and retirement. Your expertise will be essential in reviewing and approving system lifecycle documentation, as well as providing Part 11/ Annex 11 and data integrity guidance to key stakeholders.

Key Responsibilities:
  • Provide guidance on system lifecycle activities and validation strategy using a risk-based approach based on GAMP 5
  • Review and approve system lifecycle deliverables for new and modified computerized systems used in GxP areas
  • Consult with QISM team members and internal stakeholders to identify high-risk areas and focus on patient safety, product quality, and data integrity
  • Identify and escalate areas of risk or non-compliance to manager/ leadership team
  • Participate in performing Periodic Review activities of Computerized Systems
  • Provide support to regulatory inspection preparedness activities as needed
Requirements:
  • Experience performing Infrastructure Qualification activities
  • Bachelor's degree and relevant GxP work experience
  • Proficiency in using Microsoft Office applications
  • 8-10 years of experience performing validation activities
Preferred Qualifications:
  • Experience with Quality Assurance function related to Clinical Computerized Systems/ Infrastructure
  • Proficiency with regulations related to FDA/ MHRA regulations
  • Use of computerized quality management systems
  • Experience with validation of Enterprise/ Lab Computerized Systems
  • Quality metrics, dashboards, analysis, and improvement programs
  • Knowledge of GAMP and Agile validation lifecycle and methodologies
  • Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
  • Proven attention to detail and organization in project work
  • Capable of working on assigned tasks without mentorship
  • Expert knowledge of FDA regulations, ISPE guidelines, and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment and 21 CFR Part 11
Benefits:
  • 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

For more information about our company, please visit us at Verista's website.

The salary range for this position is $87,780-140,220. Verista is an equal opportunity employer.



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