This position will ensure Quality Systems Compliance via tracking and trending, leading investigations, performing cGMP Training for employees, and overseeing appropriateness of job-specific department training. Support project management activities for process improvements. Ensures current Good Manufacturing Practice (cGMP) and regulatory compliance as defined in government regulations including but not limited to 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate polices and procedures.This position will also coordinate, maintain and lead cGMP and inspection readiness training programs, ensuring all employees receive required training. Perform gap analysis to identify opportunities to improve the training program. Monitor effectivness of training programs and address areas of deficiency, as needed. Participate in development of training metrics to maintain compliance. Provide feedback, where appropriate, to departments to ensure full compliance with established procedures and processes.
Knowledge of FDA regulations for the pharmaceutical industry. Detail-oriented with expert Microsoft Office skills, including Word, Excel, Project, and PowerPoint. Proficiency in statistical software packages, such as Statgraphics, Minitab or Sigma Stat, preferred. Ability to utilize statistical tools to develop graphs for trending and evaluation purposes. Excellent oral and written communication skills with the ability to design meaningful content for training classes. Able to read complex regulations and SOPs, and transfer the information into tailored training materials. Must be able to prepare and effectively deliver presentations to small and large groups. Excellent interpersonal skills and ability to communicate with all levels of employees with varying degrees of education and experience. Proven leadership capabilities to facilitate investigations and drive action plans to completion.
Bachelor of Science degree in a scientific field, preferably biology, chemistry, or engineering. Training and compliance relations certifications (such as CQE) preferred. Minimum of 5-7 years experience in Manufacturing or Quality Assurance, with at least 2 years in an FDA regulated environment. Minimum of 3 years experience in a leadership or decision-making role.
Biotest Pharmaceuticals - 2 years ago