Senior Quality Assurance Consultant

About the role

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 floor support during manufacturing activities. Shop floor work may involve gowning and entry into manufacturing areas for direct oversight of operations. You will work in a collaborative setting with substantial interaction across Quality, Manufacturing, and Technical Operations teams, engaging regularly with cross-functional stakeholders to address quality issues and drive continuous improvement.

Pay & Benefits

This is a Contract position based out of Wilson, NC. The pay range for this position is $70.00 - $90.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

Monday–Friday, first-shift schedule, with occasional requirements to provide shop floor support during manufacturing activities.

Location

This is a fully onsite position in Wilson, NC.