6437 - Senior Quality Engineer / Senior Quality GxP Auditor

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

• 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
• CORRECTIVE AND PREVENTIVE ACTIONS (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.

Requirements (Continued)

• Onsite job requirement in Boston, MA

Pay

• National (US) Range: $70,491 USD - $113,521 USD

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

About the Role

• Empower growth and innovation within the scientific community
• Help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges
• Empower informed decision-making through innovative solutions and services
• Grow through a team environment and shared mission to enable life sciences clients to improve lives
• Commit to client success at every turn
• Have the courage to do the right thing
• Encourage an inclusive environment where colleagues feel respected, engaged, and challenged
• Accumulate new skills and learn from experiences to enhance collective expertise

Qualifications

• Empower and support colleagues
• Commit to client success
• Have the courage to do the right thing
• Encourage an inclusive environment
• Accumulate new skills and learn from experiences

Skills

• Empower and support colleagues
• Commit to client success
• Have the courage to do the right thing
• Encourage an inclusive environment
• Accumulate new skills and learn from experiences

Benefits

• 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