Job Information
Curia Director, Compliance & Quality Systems in Albuquerque, New Mexico
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 strongly preferred working with third-party contract manufacturing in the Pharmaceutical industry
Supervisory Responsibilities:
This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.
Other Skills and Abilities:
Leads with integrity and respect
Provides guidance, coaching, and mentorship to team members
Demonstrates business acumen
Fosters a collaborative and positive work environment
Champions change
Coaches and Develops
Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
Demonstrates strong attention to detail
Facilitate the revision and release of all controlled documents. Facilitate mandatory reviews of SOPs and month end reports. Provide oversight for projects to update/maintain official document templates
Direct and manage the Change Control System. Direct and lead the Quality staff and the Curia facility in assuring that all changes to equipment, products and processes are appropriately documented, executed, tracked, and approved
Manage the change control process among all plant management groups, coordinating changes and communicating changes to staff and customers in order to meet requirements for quality, safety and efficacy of products.
Manage the interface on internal quality issues, customer concerns and regulatory issues.
Provide QA oversight and follow-up on non-product specific deviations related to utilities, facilities and equipment. Develop annual goals and objectives for department and manage the overall functions of the Compliance and Quality Systems Department
Direct the Regulatory Affairs and Compliance function for annual product reviews: direct the preparation of the annual product reviews (annual reports, as required) and ensure they are timely and accurate. Review the reports for trends and implement corrective actions, as applicable
Quality Agreements: oversee the establishment of Quality Agreements with new customers; assist with negotiating the terms set forth in the agreement
Oversee the negotiation of changes/updates to existing Quality Agreements
Monitor adherence to the terms of the Quality Agreement.
Audits: Responsible for site internal audit and inspection readiness program
Lead and coordinate the activities to support regulatory inspections
Review audit observations and final audit reports from internal/external audits, customer audits and Regulatory inspections
Review corrective/preventive actions and ensure timely completion of commitments
Verify corrective and preventive actions are appropriately implemented site-wide
Drive Curia network inspection gap assessment at the site to identify compliance risks and ensure mitigation actions are in place
Direct the Quality Systems deviation investigations team to ensure thorough review and timely closure of all deviations
Metrics & Site Quality Planning: Owner of site Quality Management Review process
Direct the preparation of monthly and quarterly metrics for Exception Management System, CAPAs, Change Controls, and Audits for corporate and quality management review
Drive site Quality Improvement Planning processEnsure that proper registrations and agency submissions are current and appropriate
Ensure that regulatory agency actions are monitored, both in terms of published regulations and in benchmarking of inspection trends with other companies
Provide training on quality systems and cGMPs to the QA group and Production
Provide information to customers on quality systems and quality improvement plans
Responsible for maintaining the Supplier Quality Audit program. Preferred: Supplier Quality Audit experience and certification.
Other Qualifications:
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
#LI-MM2