Senior Quality Lead, GMP & Regulatory Excellence

Regulatory Jobs; Plainville (MA); Sur place; USD 104 000 - 156 000; Plein temps

Avantages offerts par ce poste

Healthcare

Annual bonus

Paid PTO

401(k) plan

Life insurance

Résumé du poste

Thermo Fisher Scientific in Massachusetts is seeking a Senior Quality Specialist to lead regulatory-compliant quality programs across GMP operations. You will guide investigations, CAPAs, risk assessments, and documentation to uphold global standards.

Expertise in FDA/EMA regulations, quality systems, and cross-functional collaboration will drive continuous improvement and customer confidence in our pharmaceutical and biotech initiatives.

Qualifications

• Advanced degree with 6+ years in GMP QA in pharma/biotech preferred.
• Certifications such as ASQ CQE or CQA are valued.
• Strong knowledge of FDA, EMA, and global GMP regulations including 21 CFR Parts 210/211 and ICH guidelines.

Responsabilités

• Lead investigations and manage CAPAs to ensure compliance.
• Oversee risk assessments and change control within GMP environments.
• Collaborate cross-functionally to drive quality improvements and regulatory readiness.

Connaissances

GMP knowledge

Regulatory inspections

CAPA investigations

Risk assessment

Root cause analysis

Documentation

Project management

Cross-functional collaboration

Quality systems

FDA/EMA knowledge

Quality writing

English proficiency

Formation

Advanced Degree

Bachelor's Degree

Outils

None

Description du poste

Thermo Fisher Scientific in Massachusetts is seeking a Senior Quality Specialist to lead regulatory-compliant quality programs across GMP operations. You will guide investigations, CAPAs, risk assessments, and documentation to uphold global standards.

Expertise in FDA/EMA regulations, quality systems, and cross-functional collaboration will drive continuous improvement and customer confidence in our pharmaceutical and biotech initiatives.