Site Quality Head

Hartmann Young; New Mexico; On-site; USD 180,000 - 240,000; Full time

Job summary

Hartmann Young is seeking a Site Head of Quality to establish and maintain the site quality system in line with regulatory expectations and cGMP requirements. You will lead the QA & QC organization, including chemistry and microbiology labs, ensuring quality decisions are technically sound and compliant.

Responsibilities include oversight of GMP compliance, guidance on cross-contamination controls, process improvements, and maintaining global quality systems.

Qualifications

• Bachelor's degree in Science, Business Management, Engineering, or related field.
• 10+ years of related quality operations experience in pharma/biologics/medical devices.
• 5+ years in professional management roles.
• 5+ years in pharmaceutical industry including vaccine manufacturing operations.

Responsibilities

• Provide leadership to QA & QC and guide quality decision-making.
• Ensure GMP compliance across manufacturing and packaging operations.
• Oversee microbiology and chemistry laboratories.
• Drive continuous quality and cost improvement efforts.
• Implement global quality systems across site operations.

Skills

Leadership

Quality oversight

Regulatory compliance

Education

Bachelor's degree in Science, Business Management, Engineering or related field

Tools

TrackWise

EduNeering

Documentum

Job description

Summary

The site head of quality will be 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 organisation (QA & QC) by providing leadership and guidance in quality decision-making. The QC laboratories include both chemistry and microbiology teams.

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 the companies 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.