Manager, Quality Compliance

Manager, Quality Compliance – Albuquerque, NM Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life‑saving treatments to patients. Curia’s mission is to advance our customers’ therapies from curiosity to cure and ultimately improve patients’ lives. 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 401(k) program with matching contributions Learning platform And more! Summary The Manager of Quality Compliance is a critical leadership role within the Curia Albuquerque team, overseeing key elements of the Quality System to ensure sustained regulatory compliance and continuous improvement. Responsibilities include leading internal and external audits, managing Annual Product Quality Reviews (APQRs), and supporting customer and regulatory interactions. The manager ensures alignment with Curia Global Standards and applicable regulatory guidelines, including ICH Q10, FDA 21 CFR Parts 210/211, EMA, and other international health authorities. The role will lead the inspection readiness program, facilitate gap assessments, and drive remediation plans to address audit findings. The manager provides strategic guidance to site teams on Quality System improvements, supports Quality Improvement Plans (QIPs), and uses metrics to monitor trends and identify areas requiring action. Essential Duties And Responsibilities Lead and manage the APQR process to ensure timely and accurate completion of customer reports. 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. Maintain and improve the site’s inspection readiness program. Perform and lead gap assessments 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 elevate issues requiring 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. Education And Experience Bachelor’s degree in Science or related field. Minimum of five (5) years relevant experience in quality assurance and/or compliance/auditing. Minimum of two (2) years in a team‑leadership role of professional‑level individual contributors. Minimum of five (5) years in the pharmaceutical industry, aseptic/sterile product facility or related industry. Supervisory Responsibilities The 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. The manager fosters a positive work environment, provides guidance and support to team members, and evaluates performance to drive continuous improvement and achieve departmental and organizational objectives. Language Skills The ideal candidate can read and interpret safety instructions, SOPs, technical procedures, and governmental regulations, and has strong written and verbal communication and presentation skills. Mathematical Skills Proficient in executing arithmetic operations across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Strong grasp of algebraic and geometric principles. Reasoning Ability Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret technical instructions and handle abstract and concrete variables. Computer Skills Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and manufacturing software tools, including internet software. 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 identifying and addressing hazards. Demonstrates strong attention to detail. Proficient in problem‑solving techniques with limited supervision. Technical resource for routine compliance issues. Reviews reports and documents for completeness and accuracy. Organizes time for multiple tasks and responds to high‑priority tasks. Delivers assigned tasks on time. Technical writing skills and knowledge of technical terminology. Assesses and communicates regulatory risks. Knowledge of aseptic processing and regulatory guidelines. Trains and counsels quality professionals and production personnel. Knowledge of CGMPs, GDPs, and sound quality/regulatory principles. Other Qualifications Must pass a background check. Must pass a drug screen. May be required to pass Occupational Health Screening. Physical Demands Physical demands vary by position. Regular lifting, pushing, pulling up to 10 lb frequently; up to 25 lb occasionally; up to 50 lb infrequently. Requires regular sitting, standing, reaching, visual acuity, hand dexterity, and occasional stooping, kneeling, twisting. May involve climbing and work at elevated heights as required. Work Environment Work environments include office, manufacturing, or warehouse. The office is temperate; the pharmaceutical manufacturing environment is sterile, requiring aseptic gowning and PPE. The warehouse may involve refrigerated or freezer temperatures. Exposure to moving mechanical parts, elevated heights, airborne particles, electrical activities, vibration, or compressed gases may occur. All environments may expose employees to cleaning agents. Legal Statements 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. #J-18808-Ljbffr curiate.co