Site Quality Head

Site Quality Head 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 Site Head of Quality at the Albuquerque, NM facility is responsible for establishing and maintaining the site quality system to meet the regulatory expectations and cGMP requirements for various global regions. This position’s responsibilities include leading the site Quality organization, which consists of Compliance & Quality Systems, Quality Operations (IQA, MQA and Sterility Assurance), Validation, and Quality Control by providing leadership and guidance in quality decision making. The Quality Control laboratories include both the chemistry and microbiology teams.  The Site Head of Quality is also responsible for directing and providing leadership for the implementation of Curia global standards and procedures to ensure quality decisions are made conforming to highest standards and in the successful operation of the Quality Organization.

Essential Duties and Responsibilities

• The site head of quality provides technical, quality oversight, and support to the VP of Quality operations in making quality decisions. 
• Ensures adequate manufacturing quality oversight across manufacturing and packaging operations.
•  Responsible for all aspects of GMP compliance.  This includes quality oversight from the point of material dispensing through final product dispatch for all products.
•  Provide guidance and processes that would comply with global cross-contamination control requirements including vaccine manufacturing.
• Provide oversight and direction to the microbiological and chemistry laboratories.
•  Support plant management groups on new products, changes to products, processes, and services to achieve a consistent approach to quality assurance and regulatory affairs. 
• Direct quality and compliance process improvements and goals for the site using current regulations and demonstrated best practices.
• Support effective and efficient continuous quality and cost improvement efforts. 
• Ensure requirements of Curia global quality systems are implemented and maintained in each operation throughout the facility.
•  Drive accountability for all decisions made affecting product and process quality.
• Provide leadership and direction to the quality organization throughout the company. 
• Evaluate and recommend solutions and implementation strategies for product/process issues through the use of analytical, technical, and leadership skills. Contribute to core values of quality, timeliness, communication, and profitability.
• Direct and manage the manufacturing quality assurance function: includes monitoring the quality aspects of manufacturing, facilitating incoming quality assurance activities, and ownership of the environmental monitoring system (EVM).
• Direct and manage the quality control function: includes the microbiology laboratory, the chemistry laboratory, environment monitoring, in-process, and finished product release testing, and stability.
• Direct and manage the quality systems function: includes validation, regulatory affairs, compliance, quality systems (TrackWise, EduNeering, and Documentum), quality engineering, quality assurance documentation, and change control.
• Direct and manage the quality assurance product specialist (QAPS) function: includes coordination of lot release, product-specific expertise concerning manufacturing processes, coordination of investigative activities, constant customer contact to establish, and maintain a beneficial relationship.
• Provide plant management with data and information appropriate to reduce the potential for regulatory action and assist in site productivity management. Keep plant management advised concerning agency, customer, and internal audit compliance commitments. 
• Responsible to implement an effective training system at the time.
• Provide technical expertise and internal technical consulting within the facility. 
• Responsible to develop and maintain a quality budget on site. 
• Other duties as assigned.

Education and Experience:      

• Bachelor’s degree in Science, Business Management, Engineering, or related field of study
• Minimum of ten (10) years related work experience with progressively greater responsibilities in quality operations in the pharmaceutical (sterile product manufacture) / Biologics / medical devices industry, including project, technical, and personnel management. 
• Minimum of five (5) years in a professional management role.
• Minimum of five (5) years of experience in the pharmaceutical industry, including vaccine manufacturing operations within an 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
• Demonstrated leadership experience in promoting a culture of organization development and change, succession planning, and operational excellence. Demonstrated experience in vaccines/biologics quality operations.
•  Ability to define, build, and implement a robust quality system, consistent with regulatory expectations.
• Provide strategic guidance to the CURIA Albuquerque site, and align site objectives with the corporate vision. 
• Superior influence, negotiation, and communication skills. 
• Demonstrated ability to interface with customers during deviation resolution, business development activities, and audits. 
• Solid knowledge in FDA, EMA, and ICH regulations, particularly in the aseptic manufacturing space.

Other Qualifications:

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• May be required to obtain and maintain gowning certification 
• 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. 

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-KL