We are seeking a QC Manager to be responsible for all facets of managing the QC department and to oversee the Environmental Monitoring and Biology Testing Programs. This role is responsible for interpreting regulations and ensuring compliance with departmental policies and procedures, managing multiple quality systems, leading QC system improvement projects, performing high-level QC data analysis and serving as the technical resource for the QC department. The Manager will manage and develop QC personnel, interface with Manufacturing, Facilities and Quality Assurance leadership and participate/lead interdepartmental teams to address quality-related issues.

 

Essential Duties & Responsibilities:

  • Participate in the development, implementation, enhancement and maintenance of QC systems.

  • Evaluate  QC systems and recommending and/or implementing system improvements.

  • Conduct laboratory investigations and writing reports for deviations, Environmental Monitoring excursions, and Out of Specification results.  

  • Oversee the Environmental Monitoring Program by reviewing EM data, EM excursion investigations and EM reports and the Biology Testing Program with scheduling testing, reviewing biology data, investigate OOS and OOT results.

  • Ensure development and implementation of testing programs meet departmental, company, and regulatory compliance requirements.

  • Develop effective partnerships with other departments to facilitate problem solving and resolution of issues.

  • Write/revise test methods and SOPs. Writeand review QC technical protocols and reports.

  • Manage QC files and Environmental Monitoring electronic databases.

  • Evaluate electronic database systems for implementation into QC.

 

Competencies:

  • Excellent critical thinking and technical writing skills.

  • Excellent interpersonal and communication skills and be able to lead and follow  

  • Ability to work effectively and efficiently on independent tasks as well as to accept direction on given assignments or in a team environment.

  • Must have the following personal attributes: personal accountability, work ethic, sound judgment, strong organization skills, and attention to detail, eagerness to learn and continuously improve, systematic approach, and a dedication to quality.

  • Must behave professionally and have respect for individuals and the diverse contributions of all.

  • Computer skills required to operate Microsoft Word, Project, Visio and Excel programs.

 

Managerial Responsibilities:

  • This person has direct reports and responsible for regular 1:1 meetings, performance/coaching/counseling as required, career development, time sheet management and annual performance reviews.

 

Education and Experience:

  • B.S. or B.A. in microbiology or related field.

  • At least 10 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.

  • At least 3 years of management experience is required.

  • 5 years of Environmental Monitoring experience is required.

  • Method validation experience is a plus.

  • Demonstrated ability to apply the comprehensive understanding of QC guidelines, regulations, and current industry practices, including cGMPs and aseptic processing guidelines.

  • GMP instrument qualification/validation experience is a plus.

  • Cell Therapy experience is preferred.

 

We hire talented people who thrive in an innovative environment and who are excited to see results.  We offer competitive compensation and benefits and a stable but challenging place to find their work home. The position is located in San Diego, California.



 

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