Director, Compliance & Quality Systems

Director of Compliance and Quality Systems in Albuquerque, NM

 

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

 

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. 

 

We Proudly Offer:

• Generous benefit options (eligible first day of employment) 
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities 
• Education reimbursement
• 401k program
• Learning platform
• And more! 

 

Summary:

The Director of Compliance and Quality Systems is responsible for ensuring the site’s adherence to GMP regulations and maintaining a robust quality management system. This role provides leadership in the development, implementation, and continuous improvement of key quality systems, including Deviation Management, CAPA, Change Control, Supplier Quality, and Regulatory Compliance. The Director oversees the generation, review, and approval of controlled documents such as SOPs, Master Batch Records, and Regulatory Filings, ensuring alignment with industry regulations and company standards. This position plays a critical role in maintaining inspection readiness, acting as the primary liaison for internal and external audits, regulatory inspections, and quality-related customer interactions. Additionally, the Director drives compliance initiatives, fosters cross-functional collaboration, and implements quality process improvements to support operational excellence and regulatory expectations.

 

Essential Duties and Responsibilities:

• Lead the site Quality System and Compliance program at the site. System owner for deviation, CAPA, Change Control, and other quality system processes at the site. 
• Provide leadership to the Quality Systems Manager, Quality Compliance Manager, and the Quality Assurance Documentation department in establishing and maintaining regulatory compliance based on industry and regulatory requirements. 
• Ensure products manufactured follow regulatory expectations and submissions. 
• Establish and maintain robust inspection readiness program at the site.
• Lead internal/external audits, host regulatory inspections, and co-host customer audits, as needed. 
• Oversee the negotiation of Quality Agreements with customers and monitor compliance with the terms of the Quality Agreements. Support plant management groups on new products, changes to products, processes, and services to achieve a consistent approach to quality.
• Provide oversight to the Quality Systems Department responsible for monitoring, trending, and managing the CAPA and Exception Management Systems.
• Owner of Quality Management Review program to monitor the health and effectiveness of the quality systems. 
• Drive continuous improvement programs to maintain quality performance of the site.
• Lead the site supplier qualification program.
• Direct quality and compliance process improvements and goals for Curia using current regulations and demonstrated best practices. 
• Support effective and efficient continuous quality and cost improvement efforts.
• Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.
• Other duties as assigned

 

Education and/or Experience:

• Bachelor's degree (BS or BA) in a scientific or related field from an accredited college
• Minimum of ten (10) years Quality Assurance or Regulatory Compliance work experience
• Minimum of five (5) years in a professional management role
• Minimum of ten (10) years of progressively greater responsibilities in the pharmaceutical products/medical devices industry, including QA and/or Regulatory Affairs, and relevant experience in change control management
• Minimum of ten (10) years in Demonstrated understanding of laboratory, manufacturing, packaging, regulatory affairs, compliance, and quality assurance requirements for biological and drug product manufacturing
• Experience