Director, Quality Assurance
Posted on: February 11, 2020
Mission The Director, Quality Assurance is an influential
hands-on leader of quality operations and quality management
systems for AGTC. Reporting Relationship
- The Director, Quality Assurance reports directly to the
Executive Director, Regulatory Affairs.
- Quality Assurance and Quality Control personnel report to the
Director, Quality Assurance. Essential Duties and Responsibilities
- Develop and improve quality systems, programs and procedures to
promote, facilitate, and ensure compliance with domestic and
international regulatory and industry standards and implement
risk-based methodologies to improve efficiencies.
- Institute key quality processes, metrics and indicators to
measure, trend and improve quality determinants of all aspects of
GLP, GMP and GCP.
- Direct Quality Control activities for the collection, review
and maintenance of product testing documentation.
- Provide leadership for vendor identification, evaluation and
- Facilitate the authoring and implementation of Quality SOPs and
the management of SOPs for other functional groups within
- Facilitate the review and approval of study protocols, study
reports, batch production records and other controlled
- Provide or facilitate GxP training of AGTC staff while
developing and maintaining a training documentation system.
- Work closely with Operations, Finance, and R&D to promote
effective teamwork and work proactively and collaboratively to
provide prompt solutions and improved processes designed to address
- Communicate an engaging quality mission to each key functional
area to inspire proactive attention to this critical area within
- Maintain active involvement in biotechnology and Quality
Assurance organizations to ensure up-to-date knowledge of current
and future industry trends related to FDA, ICH and GxP regulations
- Provide technical leadership and vision by interpreting
regulatory compliance initiatives and mandates, while uncovering
emerging trends regarding future regulation of drugs and
- Instill discipline and process to the company's quality efforts
to ensure the highest level of quality throughout AGTC, while
participating in the preparation of an overall expense budget and
any necessary headcount forecast for the Quality department.
- Attract, train, develop and mentor the very highest caliber of
quality employees. Develop staffing requirements and assume
responsibility for planning, recruiting, training and motivating
any necessary additional team members.
- Other duties as assigned Educational Qualifications
- Bachelor's degree required, preferably in the life sciences,
engineering or related fields
- Advanced degree advantageous and ASQ CQE and CQA Certifications
are preferred. Additional Qualifications
- Eight (8) or more years of progressive Quality Assurance
experience within the life science industry, and preferably within
the biotechnology or pharmaceutical industries specifically.
- Previous experience within smaller, more entrepreneurial drug
development companies will be considered beneficial.
- Must have in-depth understanding of GLP, GMP and GCP processes
- Strong business acumen to ensure AGTC's ability to meet
regulations and strategic objectives; and a history of leadership,
change management, clear communication, analytical thinking,
organization, and implementation skills should be evident in
his/her background. Physical Requirements
- Physical demands: --- sedentary ( --- light work ( --- medium
work ( --- heavy work ( --- very heavy work (> 100 lbs.)
- Physical activity: --- repetitive motion --- balancing
---stooping ---lifting ---climbing ---kneeling/crouching
---crawling ---reaching ---standing--- typing/grasping --- walking
---pushing/pulling --- hearing
- Visual acuity: reading, writing
- Working conditions: indoor Supervisory Responsibilities
- Previous management or supervisory experience required
- Will have supervisory responsibility for Quality Assurance and
Quality Control personnel
- One-on-one meetings with the direct supervisor will be
conducted weekly for the review of progress on work plans and data
analysis. Measures of Performance
- An initial Performance Review will be completed three (3)
months from the hiring date.
- Subsequent Performance Reviews will be conducted annually
within 60 days of the Company's fiscal year end.
- Weekly one-on-one meetings with the Executive Director,
Regulatory Affairs will be conducted for review of work plans and
Keywords: AGTC, Gainesville , Director, Quality Assurance, Executive , Gainesville, Florida
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