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Head of Quality

Colorado State University

This is a Full-time position in Fort Collins, CO posted June 16, 2021.

Working Title Head of Quality Position Location Fort Collins, CO Research Professional Position Yes Posting Number 202100021AP Position Type Admin Professional/ Research Professional Classification Title Sr Research Associate Number of Vacancies Work Hours/Week 40 Proposed Annual Salary Range $110,000
– $125,000 Employee Benefits Colorado State University (CSU) is committed to providing employees with a strong and competitive benefits package that supports you, your health, and your family.

Visit CSU’s Human Resources website for detailed benefit plan information for permanent full-time and part-time faculty and administrative professional employees in the following University benefit areas.

https://hr.colostate.edu/wp-content/uploads/sites/25/2021/01/benefits-summary-afap.pdf. Desired Start Date Position End Date (if temporary) To ensure full consideration, applications must be received by 11:59pm (MT) on 02/08/2021 Description of Work Unit BioMARC is a contract manufacturing organization (CMO) of FDA regulated products.

It was created to fill an industry need for higher containment biologic manufacturing.

BioMARC is a nonprofit CMO owned and operated by CSU,and was created to translate and produce bio-pharmaceutical products for non-clinical, clinical, and commercial use under Bio-safety level 2, 3 and Select Agent bio-security conditions.

In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementing cGMP regulations and scalability issues. Position Summary The Head of Quality is the senior most responsible individual for the quality unit.

This person is responsible for the design and implementation of policies and procedures to ensure that quality assurance (QA) and quality control (QC) standards are met during production.

Relies on extensive experience to maintain and improve a comprehensive quality system to support cGMP manufacturing.

The Head of Quality will ensure that appropriate investigations of deviations, CAPA, and OOS’s are performed and completed correctly.

Will be required to manage audits (internal and external).

Will be responsible for interactions with regulatory agencies and represent BioMARC’s quality unit to the agency.

Must lead other QA and QC personnel.

The work involves isolating and defining unknown conditions, resolving critical problems, developing new theories along with the overall planning, developing, and execution of vital programs.

The programs are essential to the missions of the overall organization or affect large numbers of people on a long-term or continuing basis. Required Job Qualifications The Head of Quality is the level to which a manager is promoted, as appropriate.+ Or to which individuals with a Bachelors degree and more than 10 years of work-related experience+ Or a Masters degree with more than 5 years of experience may join CSU.+ Individuals holding a PhD who have at least 5 years experience may also be appointed to this position upon joining CSU if it is appropriate for their role in CSU research.The Head of Quality must have demonstrated group leadership activities.

Supervisory assignments typically carry scientific management responsibility covering many departmental specialties engaged, which necessitates the effective integration of numerous subsystems and fields.With minimal supervision, the Head of Quality uses a broad knowledge of and experience with diverse research principles, techniques, and equipment to engage in extremely difficult and complex projects, making important original contributions pertaining to their respective fields of endeavor. Preferred Job Qualifications + Management experience in a contract manufacturing organization.+ Management experience in oversight of quality system in support of bio-pharma activities.+ Management experience in a regulated environment.+ Experience in engagement with U.S.

FDA regulatory authorities related to cGMP manufacturing. Diversity Statement Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.Essential Duties Job Duty Category Primary Duty/Responsibility + Provide organizational leadership, direction and training in areas such as QA, QC, safety, cGMP, GDP, etc.+ Provides final decisions for critical quality assessments for each project through the monitoring of incidents and CAPAs; including the mitigation, closure and archiving plans for incidents/CAPAs as well as all other documentation of the organization.

+ Oversees all customer, regulatory and in-house audits.

Ensures the appropriate review of documentation in support of method and process validation, as well as product disposition.+ Responsible for the disposition of each project’s quality mission/goals, deliverable, resources, key participants (internal and external), deadlines, gaps and risks related to sponsorship guidelines, contract specifications, and federal code related to the research process ultimately leading to a pipeline to commercialization.

+ Provide direction and feedback on quality issues along with coordinating responses to client related issues to BioMARC Director, CSU Quality representatives and the sponsor.

Maintain and communicate clear quality directives from sponsor.+ Establishment, maintenance and adherence to all customer Quality policies and procedures as stated in the Quality Manual and Quality Agreements.+ Ensures BioMARC’s adherence to all regulatory rules and regulations, ensuring that safety and product performance standards are met.+ Act as the Sr.

quality adviser in manufacturing process and assures adherence to Manufacturing Quality System and applicable regulations.+ Builds and maintain a quality infrastructure that can ensure that quality activities and manufacturing records are in compliance with SOPs and regulatory requirements, determines the need for corrective actions, ensures proper documentation, and determines effectiveness of the action.+ Responsible for recognizing and managing each project’s quality mission/goals, deliverable, resources, key participants (internal and external), deadlines, gaps and risks related to sponsorship guidelines, contract specifications, and federal code related to the research process ultimately leading to a pipeline to commercialization.

+ Perform other duties as required. Percentage Of Time 80 Job Duty Category Secondary Duty/Responsibility + Oversees the review and audit of documentation for compliance to good documentation practices and to the technical requirements of directive documents (SOPs, protocols, directive documents, etc.).

+ Approval of organization’s expectations for quality testing, quality control, development study and other reports/data-forms for accuracy, completeness and compliance to requirements to ensure that QA standards and regulatory requirements are met.

+ Ensures correct organizational change control procedures and events.

+ Directs internal and external audits and assists departments with the coordination of audit information, and recommends appropriate improvement/mitigation.

+ Perform complex scientific and or quality data reduction requiring use of independent judgment based on relevant technical experience.+ Manage and record complex meeting actions/research discovery items, prepare meeting agendas and disseminate research project information.

+ Oversees strategic and tactical quality assurance tasks within the organization, other departments within BioMARC, the university and our sponsors.

Applies extensive knowledge of the job skills, scientific context, BioMARC and university policies and procedures to complete complex, specialized assignments/task in creative and effective ways.

Comprehensive understanding of the general/technical aspects of the job.

Work is completed with no supervision and assignments may be completed without established procedures.

May determine methods and procedures for new assignments.

Percentage Of Time 20 Special Instructions to Applicants To apply, please submit a cover letter, which addresses the minimum and preferred qualifications, a resume, and the names and contact information of three professional references.

References will not be contacted without prior notification of candidates. Conditions of Employment Pre-employment Criminal Background Check (required for new hires) Search Contact Darragh Heaslip
– darragh.heaslip@colostate.edu EEO Statement Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity or expression, or pregnancy and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

Colorado State University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action.

The Office of Equal Opportunity (https://oeo.colostate.edu/) is located in 101 Student Services.The Acting Title IX Coordinator is the Vice President for Equity, Equal Opportunity and Title IX, 123 Student Services Building, Fort Collins, CO.

80523-0160, (970) 491-1715, titleix@colostate.edu.

The Section 504 and ADA Coordinator is the Vice President for Equity, Equal Opportunity and Title IX, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836. Background Check