Site Quality Head

At-a-Glance: Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a Site Quality Head.Position Type:ContractOnsiteRequiredEducation And ExperienceBachelor’s degree in Science, Business Management, Engineering, or related field of studyMinimum 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 ResponsibilitiesAbility 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. Other Skills And AbilitiesLeads with integrity and respectProvides guidance, coaching, and mentorship to team membersDemonstrates business acumenFosters a collaborative and positive work environmentChampions changeCoaches and DevelopsPromotes 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 detailDemonstrated 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 CLIENT 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. Responsibilities:Site Head of Quality is responsible for establishing and maintaining the site quality system to meet the regulatory expectations and cGMP requirements for various global regions. 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. Site Head of Quality is also responsible for directing and providing leadership for the implementation of Client global standards and procedures to ensure quality decisions are made conforming to highest standards and in the successful operation of the Quality Organization. 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. Essential Duties And ResponsibilitiesSite 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 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. Other duties as assigned. Get in Touch:We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Vaibhav at (551) 227-9117 to learn more.#HbM6349