6437 - Senior Quality Engineer / Senior Quality GxP Auditor

Veristainc; Boston (MA); On-site; USD 70,491 - 113,521; Full time

Job summary

Verista in Boston is seeking a Senior Quality Engineer to provide QA oversight for GMP manufacturing operations supporting Cell & Gene Therapy products. You will collaborate with Manufacturing, Validation, Engineering, Facilities, Laboratory Operations, and Capital Projects to ensure GMP compliance throughout the product lifecycle.

The role requires leading GMP investigations, CAPA development, and risk-based decisions, plus review of validation documentation and electronic quality systems such

Qualifications

• Master's degree with 3–5 years of QA/Validation experience.
• Bachelor's in Engineering, Life Sciences, or related field with 8+ years of experience.
• Experience providing QA oversight of GMP manufacturing operations.
• Experience supporting validation programs and capital projects in regulated environments.
• Strong knowledge of cGMP, quality systems, and validation principles.
• Experience supporting aseptic manufacturing operations.

Responsibilities

• Provide QA oversight for GMP manufacturing operations supporting clinical and commercial Cell & Gene Therapy products.
• Partner with Manufacturing, Validation, Engineering, Facilities, Laboratory Operations, Materials Management, and Capital Projects to ensure GMP compliance throughout the product lifecycle.
• Represent Quality on cross-functional project teams as the primary QA resource for assigned initiatives.
• Identify compliance risks and communicate quality gaps, proposing risk-based solutions.
• Review and approve validation protocols and reports, equipment/utility/facility qualification docs, risk assessments, and engineering change documentation.

Skills

QA oversight

GMP knowledge

Validation experience

Root cause analysis

CAPA development

Cross-functional collaboration

Education

Master's degree in a relevant field

Bachelor's degree in Engineering/Life Sciences

Tools

Veeva

Nuvolo

ViewLinc

Job description

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 Engineer Responsibilities

Quality Oversight & GMP Operations

• Provide Quality Assurance oversight for GMP manufacturing operations supporting both clinical and commercial Cell & Gene Therapy products.
• Partner with Manufacturing, Validation, Engineering, Facilities, Laboratory Operations, Materials Management, and Capital Project teams to ensure GMP compliance throughout the product lifecycle.
• Represent Quality on cross-functional project teams while serving as the primary QA resource for assigned initiatives.
• Identify compliance risks and proactively communicate quality gaps, recommending practical, risk‑based solutions.

Validation & Engineering Support

• Provide QA review and approval of:
  • Validation protocols and reports
  • Equipment, utility, facility, and computer system qualification documentation
  • Risk assessments
  • Engineering change documentation
• Support commissioning, qualification, and validation activities associated with manufacturing equipment, facilities, utilities, and capital projects.
• Review qualification activities for laboratory instruments and manufacturing systems.

Quality Systems & Compliance

• Provide Quality support for:
  • Change Controls
  • Deviations and GMP Investigations
  • Root Cause Analysis
  • Corrective and Preventive Actions (CAPA)
• Ensure investigations are scientifically sound, timely, and compliant with regulatory expectations.
• Evaluate quality issues using a risk‑based decision‑making approach.

Facilities & Utility Oversight

• Provide Quality oversight for:
  • Preventive Maintenance (PM)
  • Calibration programs
  • Electronic Change Requests (eCRs)
  • Work Orders
• Review and approve equipment, utility, and facility trending programs.
• Support Environmental Monitoring (EM), routine facility monitoring, and utility control programs.
• Provide oversight of facility monitoring systems including Building Management Systems (BMS), Environmental Monitoring Systems (EMS), ViewLinc, pest control, and related GMP‑controlled programs.

Cross-Functional Collaboration

• Foster strong collaboration across Quality, Manufacturing, Engineering, Validation, Facilities, and Laboratory organizations.
• Participate in project meetings and provide quality guidance throughout project execution.
• Communicate effectively with stakeholders at all organizational levels while balancing quality, compliance, and business objectives.

Requirements

• Master's degree with 3–5 years of relevant Quality or Validation experience OR
• Bachelor's degree in Engineering, Life Sciences, Scientific, or related discipline with 8+ years of relevant industry experience, or equivalent combination of education and experience.
• Experience providing QA oversight of GMP manufacturing operations.
• Experience supporting validation programs and capital projects within regulated pharmaceutical, biotechnology, or Cell & Gene Therapy environments.
• Strong knowledge of cGMP regulations, quality systems, and validation principles.
• Experience supporting aseptic manufacturing operations.
• Demonstrated experience leading:
  • GMP investigations
  • Root Cause Analysis
  • CAPA development and effectiveness
• Experience reviewing validation documentation, engineering documentation, and quality system records.
• Experience working with electronic quality systems such as:
  • Veeva
  • Nuvolo
  • ViewLinc
  • Other enterprise GMP quality applications
• Onsite job requirement in Boston, MA

Salary Range

For U.S. 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.

$70,491 — $113,521 USD

*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

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For more information about our company, please visit Verista.com.