Quality Specialist

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.

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