Senior Clinical QA Lead: Audits & Compliance

Deciphera Pharmaceuticals; Waltham (MA); On-site; USD 138,000 - 190,000; Full time

Benefits offered by this job

Competitive salary and annual bonus

Comprehensive benefits package

Parental leave and family planning benefits

Opportunities for personal growth

Job summary

Deciphera Pharmaceuticals in Waltham, MA, is seeking a Senior Manager, Clinical Quality Assurance to oversee GCP activities for clinical trials. This role involves ensuring compliance with regulatory standards and working closely with clinical operations.

The ideal candidate will have over 8 years of pharmaceutical experience, a Bachelor's degree, and strong abilities in project management and compliance oversight. Deciphera offers competitive compensation and robust benefits.

Qualifications

• Must have 8+ years of direct GCP experience.
• Strong understanding of ICH E6R3.
• Ability to handle multiple projects under pressure.

Responsibilities

• Develop and maintain Clinical QA SOPs.
• Conduct internal and external audits.
• Assist with inspection readiness.

Skills

GCP pharmaceutical/biotechnology experience

Interpersonal skills

Project management abilities

Knowledge of GCP, GLP and ICH requirements

Education

Bachelor's degree or equivalent

Job description

Deciphera Pharmaceuticals in Waltham, MA, is seeking a Senior Manager, Clinical Quality Assurance to oversee GCP activities for clinical trials. This role involves ensuring compliance with regulatory standards and working closely with clinical operations.

The ideal candidate will have over 8 years of pharmaceutical experience, a Bachelor's degree, and strong abilities in project management and compliance oversight. Deciphera offers competitive compensation and robust benefits.