Supplier Quality Manager

Company Overview:

Omni Consulting Services LLC is a woman- and minority-owned engineering and CQV consulting and recrutiing firm, specializing in providing full-spectrum CQV and engineering solutions for the dynamic life science industry. We primarily serve biotech-pharma clients within the USA. Our services range from CQV, compliance, process-facilities-utilities engineering to project management. We also provide recruiting services to specific clients.

Job Overview:

We are seeking an experienced Assistant Director of Quality Assurance to lead and enhance GMP vendor management operations. This position will join our client as their salaried employee and plays a key leadership role in maintaining compliance and quality across the vendor lifecycle. We are looking for a Quality Assurance professional with a solid foundation in vendor qualification, auditing, quality agreements, and deviation management. Familiarity with regulatory frameworks like FDA, EMA, ICH, and global cGMPs is a must.

Job Title: Associate Director – Quality Assurance (GMP Vendor Management)

Job Type: Full-time (join our client as their salaried employee)

Position Summary:

Key Responsibilities:

• Lead end-to-end vendor qualification and oversight activities based on a risk-based approach
• Plan and perform GMP audits (onsite, remote, and via questionnaire), ensuring adherence to current regulatory standards
• Oversee the quality agreement lifecycle with external vendors from drafting and negotiating to ongoing revisions
• Review and process new vendor intake requests, working with internal SMEs to assess risk and ensure alignment with business needs
• Manage vendor change controls, collaborating with SMEs to evaluate impact and maintain compliance timelines
• Handle discrepancy investigations and drive CAPA development related to vendor issues (materials, services, etc.)
• Support continuous improvement initiatives within QA systems and vendor governance
• Provide timely metrics and ensure alignment with performance indicators and quality KPIs
• Act as a subject matter expert in cross-functional discussions related to vendor management and compliance strategy

Preferred Experience & Qualifications:

• Bachelor’s degree in Chemistry, Life Sciences, Chemical Engineering, or a related discipline; advanced degree a plus
• Minimum 8 years of QA experience in the biopharma, pharmaceutical, or life sciences industry
• At least 5 years of experience focused on vendor management and oversight
• In-depth understanding of global cGMP regulations and compliance systems
• Prior exposure to small molecules, biologics, combination products, or medical devices is beneficial
• Excellent technical writing, communication, and negotiation skills
• Ability to balance multiple priorities in a fast-paced environment
• Willingness to travel up to 15% as needed

Additional Info:

• Approximately 15% travel expected (domestic and international)
• Competitive compensation and opportunity for long-term engagement

📩 Interested? Apply today and be part of something impactful!