6437 - Senior Quality Engineer / Senior Quality GxP Auditor

Verista, Inc.•Boston, MA

36d•$70,491 - $113,521•Onsite

About The Position

Verista's team of experts collaborates with leading brands in the life science industry to address their business needs. The company's mission is to foster growth and innovation within the scientific community, assisting researchers, organizations, and companies in tackling critical healthcare challenges. Verista delivers innovative solutions and services that support informed decision-making, backed by substantial investment in its people and capabilities. The company's growth is fueled by exceptional individuals who thrive in a team setting and are dedicated to Verista's mission of enabling life sciences clients to improve lives. These professionals are committed to making a daily impact. 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

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

Responsibilities

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.