Quality systems manager - united states, longview (texas)
now hiring a quality systems manager / quality assurance department located in webster, tx
general summary
this role is responsible for the management and oversight of the core quality systems and driving compliance at the site, including investigation/deviation management, capa tracking, change control, risk management, training, document management, trending and reporting key quality metrics for senior management review, hosting client audits and regulatory inspections and other quality system functions, as needed. works in a fast-paced environment supporting the quality assurance/quality control departments of a cmo for clinical gmp manufacturing of cell therapy finished drug product.
shift work and/or weekend work may be required at times.
responsibilities
? manages the qa staff supporting investigation/deviation/ capa management, change control, risk management, document control, training, and quality metric tracking responsibilities.
? responsible for and administers investigation and deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
? responsible for and administers the capa tracking system for general gmp use and internal audits. track the timely completion and extension of commitments
? perform trending review of deviations and investigations, compile report and identify trends or areas requiring additional actions
? host client audits
? responsible for and administers the change control system for tracking and coordinating the initiation, execution and completion of change controls
? responsible for and administers the risk management system and track completion of risk assessments
? create and deliver quality system/compliance training as required
? compile pertinent qa metrics for senior management review
? assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a powerpoint presentation to be reviewed by senior management on a periodic basis. track action items for completion
? oversee management review meetings
? support client projects and provide quality oversight of manufacturing operations and the release of final drug product to support phase i/ii/iii clinical trials
? potential work with clients during initial and subsequent manufacturing campaigns
? maintains databases and systems used for tracking various gmp manufacturing associated support activities
? assists with the generation and/or revision of gmp documentation such as standard operating procedures
? support/host regulatory (fda, ema) inspections
? own and assists with performing internal audits
? works closely with manufacturing, facilities and quality control staff to resolve quality issues with regard to the facilities and product manufactured
? work closely with other departments and offers assistance as needed
job description
? continually evaluate systems and procedures for improvement for efficiency while ensuring compliance
to applicable regulatory requirements and standards
? other duties as assigned
education/experience
? b.s. in a life sciences discipline and 8+ years of relevant experience highly desirable – or –
? m.s. in a life sciences discipline and 6+ years of relevant experience
? 3-5 years of leadership experience
? experience within the cell therapy, biologic, pharmaceutical or medical device industry performing direct
hands-on work in a quality assurance/quality control function with a strong familiarity of general gmp
documentation
? have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve
operational, as well as routine quality tasks
? familiarity with good manufacturing practices (gmps) and 21 cfr
? familiarity with electronic systems, including microsoft access and excel
? experience supporting federal government contracts is a plus
? asq cqa (american society of quality certified quality auditor) highly desirable
? familiarity with good manufacturing practices (gmps) and 21 cfr parts 210 and 211 or quality
system regulations (qsr) per 21 cfr part 820
? sme/expert in all microsoft applications i.e. excel, powerpoint and access
? exposure to applicable biological regulations (21 cfr part 600s) or eu gps, a plus
? familiarity with electronic systems, including developing and producing reports using microsoft access
and excel
? ability to quickly learn and navigate new electronic systems
? able to work in a team setting and independently under minimum supervision
? ability to work in fast paced environment supporting the quality assurance/quality control departments
of a cmo for phase i/ii/iii gmp manufacturing of biologic bulk drug substance and sterile finished drug
product. experience supporting federal government contracts is a plus
? creative individual with excellent trouble shooting skills
? requires the ability to produce results in a fast-paced environment to meet client deadlines
physical demands:
while performing the duties of this job, the employee is frequently required to stand; sit and talk or hear. the
employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms.
work environment:
a majority of the work is completed in the following environments: office, laboratory, environmentally controlled
production suites (iso 7 & 8), and warehouse.
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
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