Mgr, WFIRM QA | WF Institute for Regen Medicin
Job Title: Mgr, WFIRM QA
Job ID: 4336
Full/Part Time: Full-Time
Job Category: Research Administrative
REGENERATIVE MEDICINE (WFIRM)
Full-time Regular, 40 hours/week
Quality Manager directs and leads the quality program within the RMCC and acts as liaison between the RMCC and Research groups. Oversees and manages the daily quality operations including but not limited to quality control, warehouse management, quality assurance and document control. Provides leadership, direction and training to lower level personnel.
Oral and/or written instructions received from management.
Education / Experience:
Master's degree in an appropriate scientific discipline or MBA and 4-8 years of related Quality experience.
Graduation from a four-year college or university with a major in life sciences or biology, chemistry or other science related discipline and 8-10 years of related Quality experience.
Reports To: Director, Translational Research
Oversees and manages the development of quality systems and activities.
Responsible for developing and maintaining; and assures compliance to GMP, GTP, GCP and GDP requirements.
Responsible for assuring compliance of quality plans and policies for entire organization.
Manages the validation program and policies.
Provides oversight for the Deviation Management and Change Control programs.
Provides technical support and final approval for all deviations, investigations and CAPAs.
Provides final approval and assurance for all quality and manufacturing documentation and activities.
Provides guidance and input concerning implementation of new Quality Control testing and procedures.
Provides management and direction for the Quality Assurance program and activities.
Provides management and direction concerning the Document Control systems and programs.
Provides oversight for the development and implementation of the Training program.
Responsible for development of quality requirements for new products, processes and materials translating into the RMCC.
Responsible for updating and maintaining current laboratory standards, processes, equipment and test methods.
Determines certification requirements for the RMCC (ISO, AABB, etc.).
Responsible for RMCC Environmental Monitoring Program.
Provides quality input and guidance on CMC sections for regulatory submissions.
Writes and/or revises documentation to support quality systems, data systems, technical issues and instrumentation.
Trains lower level personnel on all quality functions and processes.
Attends internal and external seminars, training sessions and workshops to maintain competency in evolving current GMP regulations and job functional requirements.
Provides technical support for troubleshooting activities dealing with quality functions and processes.
Takes initiative to identify opportunities for process improvement and implementation.
Skills and Qualifications:
Excellent recordkeeping and documentation skills.
Strong communication skills, both verbal and written.
Understanding of Microsoft Excel, Word and other computer software.
Outstanding interpersonal skills, high energy and motivated.
Supervisory experience required and management experience preferred.
Mgr, WFIRM QA
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