Site Quality Head

Curia · Albuquerque, NM · 1 wk ago

Quality AssuranceFull-time

About the role

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.

Responsibilities

Provide 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.
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.
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.

Requirements

This role requires a bachelor’s degree in Science, Business Management, Engineering, or a related field of study, with a minimum of ten (10) years related work experience in quality operations in the pharmaceutical (sterile product manufacture) / Biologics / medical devices industry, including project, technical, and personnel management. A minimum of five (5) years in a professional management role is also required, with a minimum of five (5) years of experience in the pharmaceutical industry, including vaccine manufacturing operations within an aseptic/sterile product facility or related industry.

Qualifications

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.
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.

Skills

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 include: