Workforce Genetics is recruiting for a Senior Director, Quality Operations for clinical-stage biopharmaceutical company with offices in 

Overview

Our client is looking for a Sr. Director of GMP Quality Operations responsible for managing quality assurance and quality control programs, reporting to the VP of Quality. The Sr. Director of GMP Quality Operations will manage all GMP quality programs and continuous improvement as it relates to internal operations and collaborations with external vendors.

While being in compliance with current Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP), the Sr. Director of GMP Quality Operations will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities.

Responsibilities:  

• Develop and implement programs that support GMP-regulated activities to ensure compliance with applicable regulatory requirements and internal procedures.
• Lead the GMP Vendor Management and Oversight Program including: developing audit schedule, performing vendor audits, and creation of quality agreements.
• Represent Quality on project teams and act as the GMP Quality lead for the oversight of all Quality aspects performed at manufacturing and testing partners.
• Lead Management and Product Reviews.
• Review and approve GMP related documentation including but not limited to SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, protocols.
• Prepare Key Performance and Quality Metrics
• Support validation activities related to facility, equipment, processes and computerized systems at contract facilities.
• Partner with the VP of Quality in creation of department goals and metrics.
• Communicate and promote a culture of quality and operational excellence
  

Preferred Qualifications: 

• A Bachelor's degree in a scientific or technical discipline is required. An advanced degree is preferred.
•  A minimum of 15 years of experience in a GxP in biotechnology or pharmaceutical environment is required.
• Leadership experience in building high performing teams.
• Experience in developing and implementing Inspection Readiness and PAI Plans.
• Extensive knowledge of US cGMP and GDP compliance regulations and industry practices, as well as EU GMP requirements.
• Ability to critically evaluate and troubleshoot complex problems and attention to detail.
• Strong leadership and management skills.
• Ability to manage multiple priorities and aggressive timelines