Senior GMP Quality Lead: Compliance & Process Improvement

Advanced Clinical; Marlborough (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability Insurance

401k benefits

Job summary

Advanced Group is seeking an experienced Quality Assurance professional to support quality and compliance activities within a regulated manufacturing environment in Marlborough, MA. The role partners with cross-functional teams and external service providers to ensure products are manufactured, tested, and released in compliance with applicable quality standards and regulatory requirements.

The position involves participation in cross-functional projects, review of manufacturing and testing

Qualifications

• Experience in a regulated industry (manufacturing, life sciences, healthcare, biotech, pharmaceuticals, medical devices)
• Knowledge of quality systems and regulatory requirements
• Experience reviewing technical documentation and participating in quality-related decision making
• Strong analytical, problem-solving, and organizational skills
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively in a fast-paced environment

Responsibilities

• Participate in cross-functional teams to support quality initiatives and projects.
• Review manufacturing, testing, and quality documentation for compliance.
• Support product release activities and quality oversight across the lifecycle.
• Collaborate with internal and external stakeholders to support manufacturing operations and quality improvements.
• Review and support validation and qualification activities, as applicable.
• Assist with maintenance and continuous improvement of quality systems and documentation.
• Support investigations, CAPA, change management, and other quality processes.
• Analyze quality data and metrics to identify trends and opportunities for improvement.
• Contribute to periodic quality reviews and compliance assessments.

Skills

Quality systems

Compliance knowledge

Documentation review

Analytical skills

Communication skills

Independent worker

Education

Bachelor's degree in scientific/engineering/technical field

Job description

Advanced Group is seeking an experienced Quality Assurance professional to support quality and compliance activities within a regulated manufacturing environment in Marlborough, MA. The role partners with cross-functional teams and external service providers to ensure products are manufactured, tested, and released in compliance with applicable quality standards and regulatory requirements.

The position involves participation in cross-functional projects, review of manufacturing and testing