Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07252 About our client Our client is a leading tissue therapy and development company headquartered in Florida. They are entering a significant growth phase and have strong funding from major government agencies. With an experienced management team and empowering corporate culture, this is a great opportunity for an entrepreneurial candidate that wants to put their drive and initiative to work! Position Location Quality Manager FL Salary Highly competitive package, commensurate with experience Responsibilities 1) Work with Production to develop validation and qualification plans, protocols, training and fulfillment of such procedures 2) Supervise QA staff and provide direction for daily activities to include problem-solving and mentoring 3) Oversee planning, organizing, communicating and motivating employees and prioritize workday schedule 4) Serve as the systems expert for the overall systems and subsystems that work together as part of the GMP and Quality Management System 5) Know how the systems interrelate and what are the SOPs and documents that are the outputs of these systems in order to optimize these systems and create new ones, as needed 6) Oversee records management for the GMP and Quality Management Systems and optimize as needed 7) Apply the key quality requirements of GTP, Donor Eligibility and FDA requirements to the products that BT manufactures 8) Ensure that adequate written procedures are in place and that they are being followed as well as maintain the document control system 9) Manage and oversee the employee training program and continuing education program as it related to the Technical Division to include developing training plans and competency assessment 10) Ensure that adequate validation procedures have been performed 11) Oversee and manage the final product release of tissue/device products 12) Ensure that products released meet quality and regulatory standards 13) Manage the auditing program 14) Schedule and perform internal audits and periodic external audits 15) Prepare and review corrective action reports, deviation reports, nonconformance reports, customer complaints relating to the tissue, device or cell-based products 16) Oversee the GMP Change Management System 17) Track and trend quality performance data to monitor and report on all quality issues to the Quality Management Representative 18) Serve alternatively as a Quality Management Representative 19) Oversee and manage quality initiatives such as ISO certification, industry best-practices initiatives and continuous improvement activities 20) Perform  the  functions  necessary  for  the  effective  management  of  the  QA  Department, including provision for the selection and development of employees, budget administration, employee safety, employee counseling and motivation 21) Work with other department managers to resolve quality issues 22) Develop/present  metrics  to  EVP  Technical  &  Regulatory  Affairs  to  identify  quality performance/trends 23) Regulatory Support 24) Function as a team member, as needed, on regulatory project teams 25) Assist with the coordination and preparation of FDA submissions (registrations, new submissions and annual reports for, Doffs, Indus, Nodes, Orphan Drugs, 510(k), Cosmetics, etc.) and Product Foreign submissions/Product Dossiers 26) Complete regulatory document requests/questionnaires 27) Manage regulatory  due  dates  schedule  maintenance  for  deadlines  due  to  regulatory  agencies such as the FDA and for the upkeep of regulatory files as directed 28) Review donor record for eligibility/suitability and regulatory donor release per  FDA  regulatory  requirements  to  ensure  that  donors  released  meet  quality  and regulatory standards 29) Review  and  edits  sales  and  marketing  literature  as well as  presentation  materials  to  meet quality requirements and company policy 30) Serve  as  the  subject  matter  expert  on  GTP  regulatory  requirements  for  the  Technical Division  and  provide  support  to  Technical  Operations  regarding  FDA’s  GTP  donor eligibility and other core GTP requirements 31) Coordinate with HR Service Company to schedule OSHA training to all new employees and on an annual basis thereafter 32) Monitor  and  maintain  employee-training  plans  to  ensure  compliance  with  federal  and state regulations 33) Ensure that OSHA regulations are in effect and enforced 34) Perform other duties and projects as assigned Requirements 1) Minimum 5 years of working experience in a FDA-regulated industry 2) QA and management experience 3) Experience in using electronic quality management system 4) Ability to think critically, solve problems and respond proactively 5) Excellent communication skills (both written and oral) 6) Strong time-management skills 7) Fluent (oral/written) English 8) Computer Proficiency – Word, Excel and Access
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