Sr. Director, Regulatory Affairs

Company: LFB Biopharmaceuticals
Location: Framingham
Posted on: February 25, 2021

Job Description:

It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business.- 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 less than 20%.If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Posted 30+ Days Ago Full time 2020-1405 About Us Today, LFB is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with plasma-derived or recombinant medicinal products in three major therapeutic areas: immunology, haemostasis, and intensive care.
--Life of patients is our purpose! Let's Work together in a climate of sharing, mutual exchange, trust and transparency.
We are committed to hiring a diverse and talented workforce. AA/M/F/D/V. This organization participates in E-Verify.

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