Job Title: Head, Quality Assurance and Compliance
Site: Weston, Florida
Function: Quality Assurance
Summary
Reporting to the CEO, the Head, Quality Assurance (QA) and Compliance will provide 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 design, development, 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 the design, planning, monitoring, controlling, training and management of aseptic operation to ensure the site maintains a best-in-class system for sterile product quality assurance.
Essential Duties and Responsibilities
- Develop and 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.
- Develop, 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.
- Conduct and manage internal and external audits to ensure compliance to all relevant policies and procedures as required.
- Lead the participation, coordination, and responses to audits and inspections.
- Administer, develop, and 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.
- Approve clinical investigation medicinal product label text and proofs for release to production, ensuring proper quality and compliance standards are met, as required.
- Provide hands-on leadership, oversight, and execution of the Quality Assurance team by providing learning and development where appropriate.
- Direct the design and implementation of corporate & site policies and procedures with respect to aseptic manufacturing.
- Ensure the on-time initiation and closure of Sterility Assurance 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.
- Define and implement necessary facilities improvements within the existing operation to maintain current cGMP and Industry Best practices with regards to aseptic manufacturing
- Maintain Quality Assurance audit database; manage CAPA/deviation documentation and tracking system; audit/review internal and external documents; maintain company’s training records and provide overall Quality oversight to manufacturing process.
Qualification Requirements
- PhD degree in analytical chemistry, pharmaceutical sciences or related discipline with at least 5 years of experience of managing pharmaceutical QA department; BSc in related discipline with at least 10 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.
- Demonstrated experience of working with sterile dosage forms in a sterile manufacturing environment.
- 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.
- Ability to make Quality decisions related to Sterility Assurance for manufacturing, facility design, certification & maintenance, investigations, documentation, CAPA, change control, and regulatory compliance.
- 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.
- 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.