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Director of Quality Assurance
2 months ago
Robert Half is working with a client looking to hire a Director of QA. The Director of Quality Assurance (QA) oversees the quality assurance operations for a pharmaceutical logistics company specializing in third-party logistics (3PL) services for large drug manufacturers. This role ensures that all products and processes meet regulatory and quality standards in compliance with FDA, cGMP, and other applicable regulations. The Director of QA will lead a team responsible for quality oversight of warehousing, distribution, and logistics operations, working closely with internal stakeholders, third-party partners, and regulatory bodies to maintain the highest levels of quality, compliance, and efficiency. This role requires deep expertise in pharmaceutical quality assurance, supply chain logistics, and regulatory compliance.
Key Responsibilities:
- Develop, implement, and oversee the company’s quality assurance strategy, ensuring compliance with industry regulations and standards.
- Provide strong leadership to the QA team, fostering a culture of quality, accountability, and continuous improvement.
- Act as a primary contact for regulatory agencies and support audits, inspections, and regulatory filings.
- Ensure compliance with FDA, cGMP, GDP, and other applicable regulations and standards across all logistics and distribution operations.
- Monitor regulatory updates and industry trends, integrating relevant changes into company policies and practices.
- Lead internal and external audits, ensuring timely corrective actions and follow-ups.
- Ensure all product handling, storage, and transportation meet stringent quality standards and remain compliant throughout the supply chain.
- Identify and mitigate quality risks, implementing risk-based approaches to ensure product quality and patient safety.
- Establish metrics and KPIs to measure and improve quality performance, implementing corrective and preventive actions as necessary.
- Drive process improvements across QA processes and logistics operations, utilizing Lean or Six Sigma methodologies where applicable.
- Lead and mentor the QA team, providing guidance, training, and development to build a high-performing quality organization.
- Collaborate with Operations, Regulatory Affairs, Supply Chain, and other departments to support seamless integration of QA in all business functions.
- Facilitate cross-functional communication and problem-solving to address quality-related issues and ensure timely resolution.
Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field.
- 10+ years of experience in pharmaceutical or logistics quality assurance, with at least 5 years in a leadership role within a cGMP-regulated environment. Experience in 3PL logistics for pharmaceuticals is highly desirable.
- In-depth knowledge of FDA regulations, cGMP, GDP, and other pharmaceutical quality standards.
- Strong understanding of supply chain quality management in a third-party logistics context.
- Excellent leadership, communication, and organizational skills with a track record of managing cross-functional teams.
- Ability to think strategically, make data-driven decisions, and drive continuous improvement initiatives.
