Verista

6437 - Senior Quality Engineer / Senior Quality GxP Auditor

Verista • $70K — $113K *
Boston, MA 02115In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Master's degree with 3-5 years of Quality or Validation experience or a Bachelor's degree with 8+ years of relevant experience.
  • Experience in QA oversight for GMP manufacturing.
  • Familiarity with validation programs in regulated environments, particularly in Cell & Gene Therapy.
  • Strong understanding of cGMP regulations and quality systems.
  • Experience in aseptic manufacturing operations.
  • Demonstrated leadership in GMP investigations and CAPA initiatives.
  • Proficient in electronic quality systems such as Veeva and Nuvolo.

Responsibilities

  • Provide QA oversight for GMP operations in Cell & Gene Therapy manufacturing.
  • Collaborate with cross-functional teams to ensure compliance throughout the product lifecycle.
  • Act as the primary QA resource on project teams, representing Quality in various initiatives.
  • Identify compliance risks and suggest practical solutions to mitigate quality gaps.
  • Review and approve validation protocols, engineering changes, and qualification documents.
  • Support commissioning and validation of manufacturing equipment and facilities.
  • Enhance Quality support for change controls, deviations, and investigations.

Benefits

  • High growth potential in a fast-paced, people-focused culture.
  • Performance-based incentives along with competitive pay.
  • Comprehensive medical, dental, and vision insurance coverage.
  • 401(k) with employer matching contributions.
  • Generous paid time off with rollover options and holidays.
  • Tuition reimbursement to support ongoing education.
  • Paid parental leave and bereavement support.
Full Job Description
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


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.

National (US) Range

$70,491-$113,521 USD

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

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

About Verista

Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
Learn more about Verista
Size
50 employees
Industry
Enterprise Technology
Founded
2017
* Ladders Estimates

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