Site Quality Head

Responsibilities

• 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.
• Ensure requirements of Client 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.

Qualifications

• 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.