6437 - Senior Quality Engineer / Senior Quality GxP Auditor

United States·Bostonsenior

EngineeringQuality Engineer

0 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

Quality Oversight & GMP Operations Provide Quality Assurance oversight for GMP manufacturing operations supporting both clinical and commercial Cell & Gene Therapy products.

Requirements Summary

Change Controls Deviations and GMP Investigations Root Cause Analysis Corrective and Preventive Actions (CAPA) Ensure invest

Technical Tools

EngineeringQuality Engineer

Description

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

Responsibilities

~1 min read

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.

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.

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.

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.

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

~2 min read

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.

*Verista is an equal opportunity employer.

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

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