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Description
Site Head of Quality  provides global contract research and manufacturing services to the pharmaceutical and biotechnology  industries.
Summary:
The Site Head of Quality at the 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 (QA &QC) by providing leadership and guidance in quality decision making. The QC laboratories include both chemistry and microbiology teams.
The Site Head of Quality is also responsible for directing and providing leadership for the implementation of AMRI global standards and procedures to ensure quality decisions are made conforming to highest standards and in the successful operation of the Quality Organization.
Summary: The Site Head of Quality at the Albuquerque 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 (QA &QC) by providing leadership and guidance in quality decision making. The QC laboratories include both chemistry and microbiology teams.  The Site Head of Quality is also responsible for directing and providing leadership for the implementation of AMRI 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:
• 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 to 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 AMRI 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 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. o
Includes monitoring the quality aspects of manufacturing o
Includes facilitating incoming quality assurance activities o
Includes ownership of the Environmental Monitoring System (EVM)
• Direct and manage the Quality Control function. o
Includes the Microbiology laboratory o
Includes the Chemistry laboratory o
Environment monitoring o
In-process and finished product release testing and stability
• Direct and manage the Quality Systems function.  o
Includes Validation o
Includes Regulatory Affairs o
Includes Compliance o
Includes Quality Systems (TrackWise, EduNeering, and Documentum) o
Includes Quality Engineering o
Includes Quality Assurance Documentation and Change Control
• Direct and manage the Quality Assurance Product Specialist (QAPS) function. o
Includes coordination of lot release o
Includes product specific expertise with regard to manufacturing processes o
Includes coordination of investigative activities o
Includes constant customer contact to establish and maintain a beneficial relationship
• Provide plant management with data and information appropriate to reduce 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 Quality budget on site
• Other duties as assigned

Qualifications

Education and/or Experience: BS or BA in a scientific field, microbiology preferred. Minimum of 15 years of 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 years in vaccine manufacturing operations and in an aseptic/sterile product facility required. Work Environment: While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate. Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write clearly and speak effectively. Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Computer Skills: Proficient in the use of MS Word, Excel, Outlook and Access Knowledge, Skills & Abilities: 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 AMRI Albuquerque site, and to 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. Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write clearly and speak effectively. Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Computer Skills: Proficient in the use of MS Word, Excel, Outlook and Access Knowledge, Skills & Abilities: 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 AMRI Albuquerque site, and to 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.

To apply for this job please visit pharmaboard.com.