LFB USA - Director Regulatory Affairs - CMC

US-MA-Southborough
Job ID
2017-1301
# of Openings
1
Category
Regulatory
Type
Full Time
Company
LFB USA

Overview

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.).

Responsibilities

  • Serve as a member of the Quality management team and provide leadership to a team of compliance operational, technical, professional and administrative staff that may or may not be direct reports. Provides guidance in interpreting government regulations and guidelines as they apply to products and practices.
  • Ensures Quality System procedures and practices meet corporate goals and quality and regulatory standards.
  • Ensures products meet corporate and government standards and regulations.
  • Assist in establishing and managing the compiling and reporting of department performance and quality indicators. Make improvements and adjustments as required.  
  • Seeks new ideas to facilitate and establish quality metrics and KPIs with relevance. Assist the Quality Management Review in an effort to drive for continual improvement in effectiveness of the Quality Systems.
  • Assists in coordinating regulatory inspections and preparation.
  • Assist in the management of Supply Chain audits. This includes CMOs, CROs, testing laboratories, critical raw material, distribution chain, and other GXP suppliers to ensure qualification status and for establishing Quality Agreements.
  • Compliance oversight of the raw material program, vendor qualifications and QA inspection to confirm compliance with industry standards and regulations.
  • Provides CMC related input and review for internal programs across LFB Group as requested.
  • Interacts directly with LFB Regulatory departments as a CMC SME by both physical presence for such things as internal meetings, Mock Audits, input on submission development, submission reviews, and active participation in agency interactions and communications as appropriate.
  • Travel < 20%.

Qualifications

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.  

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