Manager, Quality Compliance

Manager, Quality Compliance in 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. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to 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

• 401K program with matching contributions

• Learning platform

• And more!

Summary:

The Manager of Quality Compliance plays a critical leadership role within the Curia Albuquerque team, overseeing key elements of the Quality System to ensure sustained regulatory compliance and continuous improvement. This role is responsible for 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 position leads the inspection readiness program, facilitates gap assessments, and drives the execution of remediation plans to address audit findings. This individual provides strategic guidance to site teams on Quality System improvements, supports Quality Improvement Plans (QIPs), and utilizes metrics to monitor trends and identify areas requiring action. The role requires strong cross-functional collaboration and the ability to lead compliance initiatives across departments to meet quality objectives and regulatory expectations.

Essential Duties and 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

Education and Experience:

• 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

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.

Language Skills:

The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills:

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability:

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 and deal with several abstract and concrete variables.

Computer Skills:

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

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

• 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

Other Qualifications:

• Must pass a background check

• Must pass a drug screen

• May be required to pass Occupational Health Screening

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

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.