Senior Quality Assurance Consultant

Job Title:
Senior Quality Assurance Consultant

The Senior Quality Assurance Consultant provides on-site quality oversight and support for pharmaceutical manufacturing operations focused on final drug product (fill-finish) manufacturing, labeling, packaging, and batch release activities. In this highly visible role, you act as a key quality representative, partnering closely with manufacturing, quality systems, and site leadership to ensure timely batch disposition, strict adherence to GMP requirements, and continuous improvement of quality processes.

You play a critical role in identifying and resolving issues that delay product release, driving quality decisions through to completion while influencing cross-functional teams through strong peer-to-peer communication and appropriate escalation of concerns.

• Provide quality oversight for final drug product fill-finish manufacturing operations, ensuring activities align with GMP and internal quality standards.
• Support the review and disposition of manufacturing batches through all release activities, ensuring timely and compliant batch release.
• Partner with site teams to improve batch release timelines by identifying bottlenecks and implementing process improvement opportunities.
• Provide shop floor quality support during manufacturing operations, including real-time guidance and issue resolution.
• Review and support quality system records, including deviations, CAPAs, change controls, and investigations, ensuring thorough and accurate documentation.
• Ensure all quality records are completed accurately, comprehensively, and in full compliance with GMP and regulatory expectations.
• Escalate compliance concerns and quality risks appropriately, ensuring timely communication to leadership and relevant stakeholders.
• Serve as the quality representative for manufacturing, labeling, and packaging activities, providing oversight and guidance on quality and compliance matters.
• Support inspection readiness efforts and broader compliance initiatives, helping prepare the site for regulatory and internal audits.
• Collaborate with cross-functional stakeholders to drive quality actions to completion, maintaining momentum on corrective and preventive measures.
• Identify opportunities to strengthen quality processes and enhance operational efficiency across manufacturing and quality systems.
• Partner closely with manufacturing, quality, technical operations, and leadership teams to align on quality objectives and resolve issues.
• Communicate effectively across all levels of the organization, providing clear, concise, and timely updates on quality-related topics.
• Provide constructive challenge when necessary, advocating for compliance-focused decision making and robust quality standards.

• 5–8+ years of Quality Assurance experience within a pharmaceutical manufacturing environment.
• Bachelor's degree in a scientific or engineering discipline.
• Direct experience supporting drug product (DP) manufacturing and fill-finish operations.
• Hands‑on experience with batch record review and batch release processes.
• Practical experience managing deviations, including investigation and documentation.
• Experience developing and executing CAPAs to address quality and compliance issues.
• Experience with change control processes within GMP‑regulated environments.
• Strong understanding of GMP‑regulated pharmaceutical manufacturing, including FDA and EMA expectations.
• Solid knowledge of pharmaceutical quality systems and compliance requirements.
• Experience working with CMO/CDMO environments and external manufacturing partners.
• Ability to provide quality oversight for manufacturing, labeling, and packaging operations.
• Strong communication skills with the ability to influence and collaborate across cross‑functional teams.
• Ability to elevate quality and compliance concerns appropriately and drive decisions to completion.

• Experience supporting injectable products, biologics, monoclonal antibodies, or aseptic manufacturing operations.
• Prior experience working in commercial pharmaceutical manufacturing environments.
• Experience supporting batch disposition and…