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Manager, Quality Systems 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

+ Learning platform

+ And more!

Summary:

The Quality Systems Manager leads a team that is responsible for ensuring the highest standards of quality and compliance in the manufacturing of parenteral sterile drug products. This role involves developing, implementing, and continuously improving comprehensive quality systems that adhere to regulatory requirements and industry best practices.

This position will be responsible for managing Quality Events (Deviations, Out-of-Specification), Corrective and Preventive Actions (CAPA), and Change Control processes. The manager will lead investigations ensuring effective and timely Corrective and Preventive Actions (CAPA). Additionally, they will support internal and customer audits and regulatory inspections. Supporting quality management reviews, administering department training programs, and utilizing electronic Quality Management Systems (eQMS) such as TrackWise are also crucial aspects of this role.

Responsibilities:

+ Oversee the site’s change control program, ensuring quality review and approval of changes related to documents, equipment, facilities, utilities, materials, products, computer systems, quality systems, regulatory submissions, calibration, and validation

+ Oversee the site’s Quality Event and Corrective and Preventive Actions (CAPA) programs, ensuring quality review and approval of related records.

+ Chair the site’s Quality System Review Boards and host cross-functional committee meetings to review complex changes and investigations assuring there is no impact to product quality or validated status

+ Act as the subject matter expert for quality system compliance with procedural and regulatory requirements

+ Develop and deliver training for processing Quality System records in the TrackWise Digital Information Management system, and serve as the primary quality contact

+ Review and approve due date extension requests as needed

+ Develop and author local Quality System procedures and forms tailored to the Albuquerque site while adhering to corporate procedures

+ Maintain records according to cGMPs

+ Provide oversight for the site’s Quality System program, ensuring timely quality review and approval of records and managing the performance and metrics of the systems

+ Supporting the Quality Management Review program, reporting monthly and quarterly metrics/KPIs to site leadership related to the Quality System

+ Drive continuous improvement projects through the CAPA process, collaborating with management and CAPA Process Owners to ensure effective corrective and preventive actions

+ Participate in on-site customer and regulatory agency inspections (e.g., FDA, EMA, PMDA, CFDA), presenting quality systems information, and supporting backroom activities

+ Interpret and revise SOPs to ensure cGMP compliance

+ Maintain up to date trainings

+ Other duties as assigned

Education and/or Experience:

+ Bachelor’s degree in in Science, Chemistry, Biology or related field of study

+ Minimum of five (5) years’ experience in Quality Systems or relevant related work

+ Minimum of five (5) years’ experience in a cGMP-regulated manufacturing Pharmaceutical, or Biotechnology environment, preferred

+ Minimum of two (2) years in a leadership role

+ Experience with U.S. FDA and EMEA regulations

+ Experience with process improvement and Continuous Improvements (CI) methodologies such as Lean, Six Sigma, or Kepner-Tregoe problem solving, 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.

Other Qualifications:

+ Must pass a background check

+ Must pass a drug screen

+ May be required to pass Occupational Health Screening

There may be other qualifications to add, ad hoc, such as the below:

+ May be required to obtain and maintain media qualification

+ May be required to wear a respirator

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.

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.