Senior Quality Assurance Consultant

Job Title:

Senior Quality Assurance Consultant

Job Description

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.

Responsibilities

+ 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.

Essential Skills

+ 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 escalate quality and compliance concerns appropriately and drive decisions to completion.

Additional

Skills & Qualifications

+ Experience supporting injectable products, biologics, monoclonal antibodies, or aseptic manufacturing operations.

+ Prior experience working in commercial pharmaceutical manufacturing environments.

+ Experience supporting batch disposition and product release decisions for commercial products.

+ Background in CMDO/CMO/CDMO operations and external manufacturing oversight.

+ Familiarity with inspection readiness activities and regulatory audit preparation.

+ Ability to identify and implement process improvements that enhance batch release timelines and operational efficiency.

+ Strong peer-to-peer communication and influencing skills, with the ability to provide constructive challenge.

+ Comfort working in a highly visible role with significant cross-functional interaction.

Work Environment

This is an on-site role supporting pharmaceutical manufacturing operations in a GMP-regulated environment. The position follows a Monday-Friday, first-shift schedule, with occasional requirements to provide shop…