Quality Program Manager II at CURIA GLOBAL INC

Albuquerque, New Mexico, United States -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

0.0

Posted On

02 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, cGMP Regulations, Batch Release, Deviations, CAPAs, Change Controls, Customer Complaints, Continuous Improvement, Training, SOPs, Communication, Problem Solving, Attention To Detail, Collaboration, Technical Skills, Safety Protocols

Industry

Pharmaceutical Manufacturing

Description

Quality Program Manager II, 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 Quality Program Manager II is a key member of the quality management team, responsible for ensuring the effective execution of quality programs within the framework of cGMP regulations. This mid-level role interfaces with internal and external stakeholders, including CURIA-Albuquerque customers, to manage quality-related activities, resolve issues, and facilitate batch release processes in accordance with customer and regulatory requirements. The Quality Program Manager II collaborates closely with the Director of Quality Operations to support continuous improvement efforts, identify potential risks, and drive initiatives aimed at enhancing product quality and operational performance. This role is also tasked with managing customer quality expectations, working with cross-functional teams to resolve quality issues, and ensuring the timely resolution of deviations and CAPAs. The Quality Program Manager II will contribute to developing and refining processes to meet the evolving needs of the business while ensuring compliance with both internal and external quality standards. Essential Duties and Responsibilities: Acts as the primary quality assurance contact for CURIA-Albuquerque clients Responsible for ensuring batch records have been thoroughly reviewed before product disposition to the customer within established timelines Responsible for closure of Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-Albuquerque client products Interfaces with the other CURIA-Albuquerque departments to communicate and maintain a partnership necessary for on-going operations and ensure the highest quality standards and regulatory compliance Supports CURIA-Albuquerque Compliance department during FDA and other agency inspections as well as customer and internal audits Presents project updates to internal and external stakeholders Provides all additional quality assurance support and functions as specified by the Director of Quality Operation Will act as subject matter expert for all quality issues related to batch release Will help drive continuous quality improvement initiatives Will provide quality training related to batch review, sitewide 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 study Minimum of three (3) years of GMP experience in an FDA regulated pharmaceutical environment Minimum of two (2) years of experience in a Quality position, preferred Supervisory Responsibilities: This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising. Language Skills: The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills. 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, sitewide 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 Ability to work promptly and under pressure to meet customer and business deadlines associated with batch record lot release 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. #LI-MM2

Responsibilities

The Quality Program Manager II is responsible for ensuring the effective execution of quality programs within the framework of cGMP regulations. This role interfaces with internal and external stakeholders to manage quality-related activities and facilitate batch release processes.