| Location | Weston, FL |
Position Summary:
Provides QA and compliance leadership and work with internal teams, and external auditors, to ensure compliance across all R&D and manufacturing projects of the company. The job holder will be responsible for the execution and administration/maintenance of Transpire Bio Quality Management System that is consistent with current Good Laboratory Practices (cGLP) and/or Good Manufacturing Practices (cGMP) as well as applicable regulatory requirements. Additionally, the position will have overall responsibility for monitoring, controlling, training, and management to ensure the site maintains a best-in-class system for product quality assurance.
Essential Duties and Functions:
Implement and/or revise corporate standard documents relating to GxP such as quality manuals, policies, SOPs, work instructions, forms, reference documents, in collaboration with relevant business functions.
Execute, and maintain the document control system to ensure appropriate level of Quality oversight to GxP documentation.
Review and update quality manuals, SOPs, policies and processes regularly to ensure all quality standards are in compliance with cGxP standards, FDA/EMA/MHRA/ICH and other applicable competent authority regulations and requirements.
Assist and participate in the coordination and responses to audits and inspections.
Maintain the employee training program including assessments of its’ effectiveness, in collaboration with business functions.
Ensure compliance of manufacture and testing of product for clinical studies; lead in resolution of quality non-compliance issues in production and testing at labs or at vendors; identify areas of improvement.
Establish and maintain appropriate development phase compliance requirements for product manufacture, testing, and stability; review and assess production and testing methods, specifications, validations, reference materials and test results.
Review applicable documentation from internal and external sources as well as applicable sections of regulatory submissions for compliance with documentation, established standards, and regulations.
Provide hands-on leadership, oversight, and execution of the Quality Assurance team by providing learning and development where appropriate.
Ensure the on-time initiation and closure of documents related to deviations & investigations, CAPAs, change controls, SOPs with thorough & standardized supporting documentation.
Support both corporate and site management through the identification and introduction of facility upgrades and innovative solutions that drive continuous improvement.
Qualifications Required:
BS degree in analytical chemistry, pharmaceutical sciences or related discipline with at least 5 years of experience of managing pharmaceutical QA department.
Extensive knowledge and full understanding of ICH guidelines, Pharmacopeia requirements, US and European regulatory guidelines on Chemistry, Manufacture and Control of drug products.
Extensive knowledge and full understanding of GLP, cGMP, COSHH, EH&S, relevant legal and ethical codes for pharmaceutical development and manufacture.
Experience in working in compliance with US, EU, and ICH GMP requirements, experience with writing or reviewing submission documentation, responses to regulatory inquiries and inspections.
Experience with regulatory compliance inspections. Proficiency with interpreting and implementing GXPs, FDA, EMA, ISO and ICH Regulations and guidelines.
Preferred hand-on experience with product development for inhalation dosage forms, understanding the GMP requirements of different phases of product development. Technical knowledge of analytical method qualification, process validation, establishing product specifications, and facility qualification
Skills:
Ability to make Quality decisions related to manufacturing, investigations, documentation, CAPA, change control, and regulatory compliance.
Demonstrated ability to work independently and practically, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
Strong interpersonal communication and leadership skills, ability to influence decisions up to strategic levels and effectively communicate with employees at all levels.
Strong English language skills including writing ability and oral communication.
Why Join Us?
We are a fast-growing pharmaceutical startup dedicated to innovation and improving patient outcomes. Join us to gain hands-on experience in a growing pharmaceutical business, get exposure to various functions with opportunities for career development and work in a collaborative and supportive work environment.