Strategic Quality Systems & Compliance Consultant

Efficient Auditing

San Francisco (CA)

On-site

USD 120,000 - 180,000

Full time

14 days+

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Job summary

Efficient Auditing in San Francisco seeks an experienced Quality Systems & Compliance Consultant to support clients across pharmaceutical, biotech, medical device, food, cosmetics, and chemical manufacturing industries.

You will develop, implement, and maintain QMS based on ISO 9001, ISO 13485, GMP, and other applicable standards; conduct gap assessments; lead audits and CAPA; deliver training and regulatory readiness; collaborate with QA, regulatory affairs, and operations to drive compliance

Qualifications

3–8 years in QA, QMS, GMP/ISO compliance or consulting.
Experience writing SOPs and controlled documents.
Ability to lead audits and CAPA assessments.
Strong regulatory interpretation skills.

Responsibilities

Develop, implement, and maintain QMS based on ISO 9001, ISO 13485, GMP, and other applicable standards.
Conduct gap assessments to identify weaknesses, risks, and improvement opportunities within client systems.
Oversee document control processes, including SOP development, policy updates, and controlled documentation workflows.
Support clients through regulatory inspections, certification audits, surveillance audits, and supplier evaluations.
Lead internal audits and provide actionable feedback for CAPA.