Senior QMS Lead, Compliance & Process Excellence

Tango Therapeutics; Boston (MA); On-site; USD 151,200 - 226,800; Full time

Job summary

Tango Therapeutics seeks a Quality Assurance leader to own and continuously improve the QMS framework across GMP/GLP/GCP domains. You will drive document control, training, and data integrity while ensuring compliance across functions and regions.

You will oversee change control, CAPA prevention, and audit readiness, partnering with cross-functional teams to define training requirements and governance. This role demands strong analytical and communication skills in a regulated, fast-paced

Qualifications

• Bachelor’s degree in Life Sciences, Quality, or related discipline (required).
• Quality-related certification preferred (e.g., ASQ, ISO Lead Auditor, Quality Systems).
• Training in electronic QMS platforms advantageous.
• 8–12 years in Quality Assurance or Compliance.
• Hands‑on experience managing QMS in regulated GxP environments.
• Experience supporting QMS‑related inspections and audits.
• QMS design, lifecycle management, and governance.
• GxP training systems and compliance tracking.
• Data integrity and document control standards.
• Process‑oriented, structured, and detail focused.
• Strong communication and training skills.
• Ability to simplify complex processes and drive alignment.

Responsibilities

• Own and continuously improve the QMS framework to ensure processes, document control, training, and quality records support consistent compliance across functions and regions.
• Harmonize across GxP domains (GMP/GLP/GCP) and align with applicable regulations/standards.
• Oversee document lifecycle management (authoring standards, review/approval, periodic review, archival).
• Ensure change control processes exist and are followed (QMS changes and cross-functional change impacts).
• Oversee GxP training framework (curricula, assignment rules, effectiveness checks, compliance reporting).
• Partner with functional owners to define role-based training requirements.
• Ensure QMS records are complete, traceable, audit-ready, and meet data integrity principles.
• Establish metrics and trending for QMS health (cycle time, overdue items, training compliance).
• Lead QMS simplification/optimization, including CAPA prevention initiatives based on trending and learnings.
• Prepare Quality Management Review packages: KPIs, risks, audit outcomes, CAPA effectiveness, and improvement plans.

Skills

QMS governance

GxP compliance

Training design

Data integrity

Document control

Cross-functional collaboration

Quality audits

CAPA management

Process optimization

Education

Bachelor’s degree in Life Sciences or Quality

Tools

Electronic QMS platforms

Job description

Tango Therapeutics seeks a Quality Assurance leader to own and continuously improve the QMS framework across GMP/GLP/GCP domains. You will drive document control, training, and data integrity while ensuring compliance across functions and regions.

You will oversee change control, CAPA prevention, and audit readiness, partnering with cross-functional teams to define training requirements and governance. This role demands strong analytical and communication skills in a regulated, fast-paced