Curia · 2 weeks ago
Manager, Quality Compliance
Albuquerque, NM
Full-time
Onsite
Mid, Senior Level
5+ years expCuria is a global contract development and manufacturing organization dedicated to improving patients’ lives through life-saving treatments. The Manager of Quality Compliance is responsible for overseeing the Quality System, ensuring regulatory compliance, and leading internal and external audits while driving continuous improvement initiatives.
BiotechnologyHealth CareManufacturing
Responsibilities
Lead and manage the Annual Product Quality Review (APQR) process to ensure timely and accurate completion of customer reports by leveraging internal teams and corporate (GSS) resources
Oversee and drive continuous improvement initiatives across the site to ensure regulatory compliance
Direct internal and external audit activities, including planning, hosting, and response development, to ensure alignment with regulatory expectations
Maintain and improve the site’s inspection readiness program to ensure the facility is always prepared for customer and regulatory inspections
Perform and lead gap assessments related to compliance issues; develop and execute remediation plans to address audit and inspection findings
Lead and manage the supplier qualification program
Guide cross-functional teams in the resolution of quality issues and lead implementation of Quality Compliance enhancements
Monitor Quality performance using key compliance metrics, identify trends, and escalate issues requiring immediate corrective action
Support Quality Improvement Plans (QIPs) tied to site-wide quality and compliance initiatives
Provide subject matter expertise and interpret regulatory requirements, including FDA , ICH, EMA, and other global standards
Ensure timely completion and execution of commitments related to customer audit and regulatory inspection responses
Provide compliance guidance and mentorship to internal stakeholders to ensure adherence to SOPs, regulatory standards, and company policies
Stay current with evolving GMP regulations and industry best practices to proactively identify compliance risks and improvement opportunities
Read/interpret SOPs to ensure compliance
Maintain up to date trainings
Other duties as assigned
Qualification
Required
Bachelor's degree in Science or related field of study
Minimum of five (5) years relevant experience in quality assurance and/or compliance/auditing experience
Minimum of two (2) years in a team leadership role of professional level individual contributors
Minimum of five (5) years is in the pharmaceutical industry, aseptic/sterile product facility or related industry
Ability to read and interpret various documents including safety instructions, standard operating procedures, technical procedures, and governmental regulations
Strong written and verbal communication skills
Effective presentation skills
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement
Strong grasp of algebraic and geometric principles
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form
Strong technical foundation and proven capability in effectively utilizing diverse software tools
Adeptness in manufacturing and internet software
Proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook
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
Demonstrates strong attention to detail
Proficient in problem-solving techniques and demonstrates the ability to troubleshoot with limited supervision
Technical resource for routine issues about compliance with regulatory requirements as needed
Review reports and documents proficiently for completeness and accuracy
Ability to organize time for multiple tasks and respond to high-priority tasks when necessary
Delivers assigned tasks on time
Technical writing skills and knowledge of technical terminology
Ability to assess and communicate regulatory risks
Knowledge of aseptic processing and regulatory and industry guidelines and requirements
Ability to train and counsel Quality professionals and production personnel
Knowledge of CGMPs, GDPs, as well as, sound quality and regulatory principles consistent with best practices
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
Benefits
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 with matching contributions
Learning platform
And more!
Company
Curia
Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.
1001-5000 employees
H1B Sponsorship
Curia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2025-03-07Debt Financing
2017-08-31Private Equity
Leadership Team
Steve Lavezoli
Vice President, Biologics Division
Recent News
2026-01-20
2025-10-31
thecanadianpressnews.ca
2025-10-29
Company data provided by crunchbase