Quality & Compliance Director, Sterile Injectables

Randstad USA; New Albany (OH); On-site; USD 275,000 - 285,000; Full time

Job summary

Randstad USA is seeking a Senior Director of Quality to oversee all aspects of compliance for sterile injectable production in New Albany, Ohio. You will lead cross-functional teams across laboratory operations, documentation, supplier quality, and external inspections (FDA, Health Canada) to ensure product quality and regulatory readiness.

In this role you will shape quality strategy, drive continuous improvement, manage QA operations and participate in audits with domestic and international

Qualifications

• Bachelors in Life Science or equivalent; Masters degree a plus.
• Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies.
• Minimum 10 years leading functional quality assurance; quality control, compliance, or manufacturing operations.
• Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities.

Responsibilities

• Provide leadership and direction for quality management systems, compliance, and performance goals.
• Manage regulatory inspections, customer and corporate audits, and responses.
• Oversee Quality Systems, CAPA, Deviation, Change Control, Document Control, and product release support.
• Lead on-site QA activities for production, manufacturing, filling, and transfers of sterile injectable products.

Skills

GMP

QA

Sterile Manufacturing

Regulatory Audit Prep

Education

Bachelors degree in Life Science or equivalent

Masters Degree a plus

Job description

Randstad USA is seeking a Senior Director of Quality to oversee all aspects of compliance for sterile injectable production in New Albany, Ohio. You will lead cross-functional teams across laboratory operations, documentation, supplier quality, and external inspections (FDA, Health Canada) to ensure product quality and regulatory readiness.

In this role you will shape quality strategy, drive continuous improvement, manage QA operations and participate in audits with domestic and international