Job Description
A leading pharmaceutical company is looking for a Quality Systems Consultant, who will play a pivotal role in ensuring their Quality Management Systems (QMS) meet regulatory standards, streamline processes, and maintain the highest levels of compliance and operational efficiency. This is a high-impact consulting role where you’ll work closely with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs.
Key Responsibilities:
- Evaluate existing QMS and recommend improvements to ensure alignment with FDA regulations (21 CFR Part 210/211), cGMP, and ISO 13485 standards.
- Lead the development and implementation of robust quality systems for documentation control, deviation management, CAPA, change control, and risk management.
- Ensure ongoing compliance with all applicable FDA regulations, EMA guidelines, and global standards, preparing the company for successful inspections and audits.
- Identify opportunities for process improvement and implement Lean/Six Sigma methodologies to enhance quality and operational efficiency.
- Provide training and support to staff on QMS procedures, regulatory updates, and best practices.
- Lead internal audits and support external regulatory inspections, ensuring adherence to industry standards.
- Collaborate with teams to implement continuous improvement initiatives for long-term quality system sustainability.
Qualifications:
- Minimum 5-7 years of experience in Quality Systems Management within the pharmaceutical or biotech industry.
- Deep understanding of QMS, FDA regulations (cGMP, 21 CFR Parts 210/211), and ISO 13485.
- Strong knowledge of CAPA, deviation management, document control, change control, and risk management processes.
- ISO Lead Auditor, Six Sigma, or similar certifications are a plus.
- Excellent problem-solving skills with the ability to navigate complex regulatory environments.
- Strong interpersonal and communication skills, with the ability to influence across all levels of the organization.
