Quality Systems Lead: GMP, Change Control & Compliance

Planet Pharma; Salt Lake City (UT); On-site; USD 55,000 - 69,000; Full time

Job summary

Planet Pharma in Salt Lake City is seeking an experienced QA professional to lead quality systems support, documentation management, and CGMP compliance. The role oversees change management, annual product review, and data trending, partnering across Operations, Manufacturing Science, and Quality Assurance.

You will drive Continuous Improvement projects, facilitate regulatory inspections, and ensure adherence to policies while guiding a collaborative team across internal and external

Qualifications

• Bachelor’s degree in science or related field with 7+ years pharma QA experience.
• Minimum 3 years QA in pharmaceutical production.
• Direct experience with Health Authority inspections preferred.
• Project management and advanced presentation skills preferred.

Responsibilities

• Develops and executes quality/compliance projects to improve site metrics.
• Hosts Change Control Review Board and oversees change control activities.
• Provides records management and support for compliant shutdown planning.
• Maintains CGMP compliance with SOPs and policies.
• Collaborates with operations, M-SAT, R&D, QA, and supply chain.

Skills

MS Office proficiency

LMS experience

EDMS familiarity

ERP systems

Quality leadership

Communication skills

Data analysis

Education

Bachelor’s degree in science or related field

7+ years pharma QA experience

3+ years QA in pharmaceutical production

Experience with health authority inspections (FDA/EMA/ANVISA)

Tools

Trackwise

Veeva

ERP systems

Job description

Planet Pharma in Salt Lake City is seeking an experienced QA professional to lead quality systems support, documentation management, and CGMP compliance. The role oversees change management, annual product review, and data trending, partnering across Operations, Manufacturing Science, and Quality Assurance.

You will drive Continuous Improvement projects, facilitate regulatory inspections, and ensure adherence to policies while guiding a collaborative team across internal and external