The Director of CMC Compliance will be proactive in providing strategic CMC direction in the implementation of quality strategies, policies, procedures and optimal infrastructure to ensure systems are aligned with company submissions, LFB Corporate Quality, and applicable external regulatory authorities. This person/position will work closely with a number of LFB France groups providing guidance and expertise on CMC matters and will work closely with internal LFB Regulatory groups/personnel and provide input/writing/review of CMC sections of filings. This person/position may be asked to represent or participate in LFB for Regulatory Agency interactions (correspondence, conference calls, in-person agency meetings, etc.).
BS, MS or equivalent industry experience (10-15 years) with clear practical understanding of Quality Assurance and GXPs as well as a strong Regulatory background or direct agency experience with an emphasis in CMC matters. Knowledge of all business disciplines to ensure ability to ‘partner’ with all functional departments of the organization. Demonstration of strategic planning, meeting objectives, technical and resource issue resolution. Strong leadership capabilities a must. Computer proficiency and familiarity with MS software applications. Excellent written and verbal communication skills. Ability to work and communicate with all levels within the organization. Must practice constructive engagement and have the confidence to challenge and be challenged to get the best strategies and solutions.