Director Of Quality Assurance
Company: Staffing Theory
Location: Saint Petersburg
Posted on: June 23, 2022
Job Description:
Senior Director of Quality Assurance - St. Petersburg, FLA
privately held clinical research organization in Florida is in need
of a highly accomplished Quality Assurance professional to lead the
overall strategy and conduct of Quality Assurance services within
the company.Position Summary:This position reports to the President
and works closely with the Executive Leadership Team to ensure that
Quality Assurance activities are aligned with corporate goals. May
serve as quality liaison and interact with sponsors, project teams,
sites and vendors to maintain compliance and industry standards.Key
Responsibilities:
- Participates in the development, implementation, and
maintenance of clinical development and company strategies; this
includes but is not limited to leadership in the areas of quality,
compliance, and operational excellence in all aspects of clinical
trial operations (e.g., clinical/medical, data management, clinical
supplies, statistics, quality assurance, etc.)
- Oversee the Quality Management System (QMS)
- Develops, implements, and revises standard operating procedures
(SOPs); monitors company and departmental compliance with SOPs
- Ensures operational processes, procedures, systems, and
standards are adopted and implemented consistently across clinical
trials
- ---Identifies process improvements within the company through
monitoring of Key Performance/Quality Indicators (KPIs/KQIs);
collaborates with internal and external stakeholders to ensure that
gaps are addressed appropriately
- Develops and implements training programs; this includes but is
not limited to interfacing with clinical operations teams for
audits of internal processes; promoting collaboration to ensure all
systems, processes, and their outcomes comply with applicable
international and national standards, regulations, and guideline;
and monitoring knowledge and understanding of training, systems,
processes, and policies
- Identifies compliance concerns, including but not limited to
reviewing SOP deviations that impact the company, conducting root
cause analysis, and recommending solutions
- Oversees plans and processes for development of remedial
actions and other improvement plans for Preventive Action Plans
from audits and inspections; ensures follow up on the completion
and implementation of required tasks
- Partners with external stakeholders to perform effective audits
of vendors (e.g., CROs, investigator/clinical sites) to ensure
documents are tracked and maintained within standards, including
but not limited to trial master files, clinical study reports,
protocols, etc.
- Plans, coordinates, controls, and implements continuous
improvement of processes and systems to ensure the quality and
compliance of studies; provides detailed feedback and change
management guidance for quality improvements affecting
processes
- Leads the inspection and audit management program, including
but not limited to all inspection readiness activities, inspection
conduct, and preparation of responses to regulatory entities
- Maintains understanding of new and emerging regulations;
collaborates with stakeholders to implement regulations in an
appropriate manner within the company's Quality Management System
and practices.Minimum Qualifications:
- BS/BA in Life Sciences, Pharmacy, or Nursing
- Minimum 15 years experience in clinical research in the
pharmaceutical or CRO/CMO industry, or similar organization with a
GCP focus, with supervisory experience (prefer specialized
knowledge of a therapeutic area)
- Minimum 5 years in a management role within a Quality Assurance
/ Quality Management environment, to include auditing skills
- Thorough knowledge and understanding of US and international
regulatory requirements for clinical research
- Demonstrated knowledge and application of clinical research
processes and procedures; electronic documentation systems; GCP and
GLP regulations and guidance; medical terminology; and
effectiveness in maintaining clinical quality assurance control
processes for compliance with regulations
- Experience with clinical trial management systems (CTMS)
- Able to handle sensitive and confidential information with
discretionCompany Benefits:
- Highly Competitive Compensation
- 401(k) Profit Sharing Plan & Roth IRA
- Comprehensive healthcare
- Vacation + Flexible PTO
- Flexible workplace to support work-life balanceThis position
can be hybrid or fully remote, with travel to St. Petersburg, Fl
once a month to confer with senior staff.We look forward to hearing
from you!Sorry but there is no visa support for this position.
Keywords: Staffing Theory, St. Petersburg , Director Of Quality Assurance, Executive , Saint Petersburg, Florida
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