Job Details

Join our pharmaceutical client's growing quality team in a newly created Quality Specialist position! This position leads supplier oversight, audit readiness, and corrective action systems within a regulated pharmaceutical environment. The role is responsible for building and maintaining programs that ensure external partners, internal operations, and quality systems consistently meet regulatory and organizational standards. This individual plays a key role in strengthening compliance, reducing risk, and supporting inspection preparedness.

This role can be hybrid for the right person, with a training period, although ideally, you are comfortable on-site.

Requirements of the Quality Specialist:

• In-depth understanding of FDA GMP regulations and quality systems
• Familiarity with pharmaceutical manufacturing and processing workflows
• Strong written and verbal communication abilities
• Effective leadership, negotiation, and stakeholder management skills
• Advanced analytical and problem-solving capabilities
• Experience planning, executing, and documenting audits
• Ability to interpret complex regulatory and operational data
• Sound judgment in ambiguous or fast-changing environments
• Strong organizational and time-management skills
• Ability to balance multiple priorities and resolve conflicts productively
• Proactive approach to identifying and addressing compliance risks

Key Responsibilities of the Quality Specialist:

• Design, implement, and maintain supplier quality and compliance programs for regulated vendors
• Monitor and evaluate the performance of material, product, and service providers
• Lead qualification and onboarding of new suppliers
• Draft, review, and manage quality agreements with external partners
• Collaborate with internal stakeholders across operations, sourcing, and commercial teams to review supplier performance metrics
• Establish and maintain supplier risk assessment and monitoring processes
• Manage supplier change notifications and ensure internal systems are updated accordingly
• Coordinate and oversee supplier corrective action activities to ensure timely and effective resolution
• Maintain accurate records related to vendor history, approvals, risk assessments, and performance trends
• Develop and administer internal and external audit schedules and procedures
• Own and manage the corrective and preventive action (CAPA) system, including tracking and reporting effectiveness
• Promote continuous improvement initiatives throughout quality operations
• Support regulatory agency inspections and third-party audits, including preparation and response activities

Occupational Code: 11-3051.01 - Quality Control Systems Managers