Job Description

Manager, Manufacturing Quality Assurance 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!
  

The Manager, Manufacturing Quality Assurance (MQA) is responsible for directing and overseeing all MQA activities to ensure consistent quality support of daily manufacturing operations and product lot release. This role serves as the primary Quality liaison for internal departments, providing guidance on product, process, and material issues while ensuring adherence to regulatory, corporate, and customer quality standards. Key responsibilities include in-process and final product inspections, on-the-floor batch record review, 24/7 QA oversight, and support for validation, change control, and deviation investigations. The MQA Manager leads the hiring, training, and development of MQA staff and drives continuous improvement initiatives aligned with current regulations and best industry practices. Additionally, the role supports strategic and global quality projects, fosters cross-functional collaboration, and ensures that all manufacturing operations consistently produce safe, effective, and high-quality products.

Essential Duties and Responsibilities:

• Provide daily Quality Assurance oversight and leadership to support commercial manufacturing operations, including in-process inspections, final product inspections, and on-the-floor batch record reviews.
• Serve as the primary Quality contact for internal departments regarding product, process, and material issues.
• Ensure timely resolution of quality issues to support uninterrupted manufacturing and compliant lot release.
• Maintain 24/7 availability to support urgent manufacturing or quality-related inquiries.
• Oversee and support Quality elements of validation activities, including report closures and adherence to protocol requirements.
• Review and approve quality documentation including investigations, change controls, and deviations.
• Hire, train, supervise, and develop the Manufacturing Quality Assurance (MQA) team, conducting regular performance evaluations to maintain a high-performing team.
• Provide cGMP training and mentoring to Quality and Production personnel to reinforce compliance and quality culture.
• Lead and support site-level and cross-functional strategic quality initiatives and global projects involving product changes, process improvements, or service enhancements.
• Drive continuous improvement efforts focused on quality, compliance, and operational efficiency in alignment with current regulatory expectations and industry best practices.
• Collaborate with other functional leaders to maintain alignment between quality and production goals.
• Act as the resident QA expert for manufacturing operations, providing technical guidance on compliance, product release, inspection readiness, and issue resolution.
• Ensure that all manufactured products meet regulatory, customer, and internal requirements for quality, safety, and efficacy.
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education and/or Experience:

• BS or BA in Science, Chemistry or Biology.
• Minimum of five (5) years quality assurance, regulatory compliance management or related work experience
• Minimum of two (2) years in a team leadership role of professional level individual contributors
• Minimum of five (5) years in an aseptic/sterile product facility
• Demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing
• Minimum of 10 years of progressively greater responsibilities in the pharmaceutical products/medical services industry, including QA, Regulatory, Operations, Project, Technical, and Laboratory experience, preferred
• Experience working with third-party contract manufacturing in the Pharmaceutical industry, strongly preferred

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
• Excellent communication skills, both verbal and written, with the ability to clearly express ideas in a logical, concise, and grammatically correct manner
• Strong organizational skills with the ability to manage multiple projects and priorities
• Skilled in interpreting and applying technical writing, procedures, and instructions
• Effective interpersonal skills with adaptability to achieve company goals collaboratively
• Available to support production operations on a 24/7 on-call basis
• Proficient in root cause analysis and troubleshooting
• Knowledge of aseptic processing techniques and ability to train and guide QA and production staff
• In-depth understanding of regulatory and quality standards including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA, MOH, EMEA, and FDA
• Experience with Quality Systems, including SOP development and control, computerized system validation (21 CFR Part 11), and sample distribution per PDMA
• Demonstrated leadership in audits and serving as a QA subject matter expert
• Proven ability to work independently and lead teams with strategic and innovative thinking

Other Qualifications:

• Must pass background check
• Must pass 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.