Quality Systems & Compliance Consultant

Efficient Auditing; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

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.

Skills

QMS development

Documentation control

Internal audits

Regulatory compliance

Client consulting

Education

Bachelor's or Master's degree in Life Sciences

Tools

QMS software

Job description

We are seeking an experienced Quality Systems & Compliance Consultant to support clients across pharmaceutical, biotech, medical device, food, cosmetics, and chemical manufacturing industries. This role involves developing, improving, and maintaining Quality Management Systems (QMS) aligned with ISO, GMP, and global regulatory expectations. The ideal candidate has strong experience with documentation control, QMS implementation, audit readiness, and regulatory compliance strategy.
You will work directly with clients to enhance their operational quality, reduce compliance risk, and prepare them for certification, inspections, and long-term quality maturity.

Key Responsibilities

• Develop, implement, and maintain Quality Management Systems (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 corrective and preventive actions (CAPA).
• Assist with risk assessments including FMEA, HACCP, and other risk management frameworks.
• Develop training materials and deliver sessions on quality systems, documentation practices, regulatory expectations, and audit preparation.
• Collaborate with cross-functional teams (QA, QC, operations, engineering, regulatory affairs) to ensure compliance alignment.
• Prepare quality metrics, management review materials, and ongoing compliance monitoring reports.
• Provide strategic guidance to help organizations streamline processes, reduce deviations, and achieve operational excellence.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Engineering, Biotechnology, Pharmaceutical Science, or similar fields.
• 3-8 years of experience in Quality Assurance, QMS development, GMP/ISO compliance, or similar consulting roles.
• Strong knowledge of ISO 9001, ISO 13485, GMP, FDA 21 CFR, and global regulatory frameworks.
• Experience writing SOPs, quality manuals, technical documents, and controlled documentation.
• Proven ability to lead internal audits, supplier audits, and compliance assessments.
• Excellent analytical skills with the ability to interpret regulations and apply them practically.
• Strong communication skills with the ability to guide and train teams across all levels.

Preferred Skills

• Lead Auditor Certification (ISO 9001 / ISO 13485) or Certified Quality Auditor (CQA).
• Experience in sterile manufacturing, medical devices, or biologics.
• Familiarity with QMS software applications and digital documentation systems.
• Understanding of validation processes (IQ/OQ/PQ), risk management (ISO 14971), and CAPA lifecycle management.

Why Join Us?

• Work with leading global companies that prioritize quality and patient safety.
• Contribute to projects that directly impact compliance, manufacturing reliability, and product integrity.
• Expand your career in quality, auditing, and regulatory consulting across multiple industries.
• Supportive, growth-oriented team environment with ongoing learning and development opportunities.
• Opportunities to lead major QMS implementations, certification projects, and compliance improvement initiatives.