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Kelly Services Quality Manager in Fort Collins, Colorado

Head of Quality(BioPharma)

Direct Hire

115,000K per year

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 ensures 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 the Company'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.

Duties and Responsibilities

  • 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 the Company Director, 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 the Company'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

Background Qualifications

  • Bachelor’s degree and >10 years of work-related experience

  • Master’s degree with more than >5 years of experience

  • PhD who have at least 5 years’ experience

  • 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.

  • Management experience in a contract manufacturing organization.

  • Management experience in oversight of quality system in support of bio-pharma activities.

  • 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.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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