Supervisor, Supplier Quality Mgt

Paragon Bioservices   •  

Baltimore, MD

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 239 days ago

This job is no longer available.

  • Leads and manages employees, ensures staff is fully trained, works with employees to ensure development opportunities occur, and mentors staff.
  • Manages the Supplier Qualification Program which includes establishing supplier qualification requirements, maintaining supplier lists and certification, and facilitating supplier change notification assessments. This includes but not limited to: contract laboratories and manufacturers, service providers, and material suppliers.
  • Participates in the development and improvement of corporate policies and procedures for the Paragon Supplier Quality and Auditing programs to assure alignment with current industry expectation and regulations.
  • Identifies compliance risks and works cross-functionally to identify and implement resolutions. Escalates significant compliance and/or business risks to management.
  • Oversees external and internal auditing schedules to assure adherence to internal operating procedures and GMP regulations.  
  • Leads/participates in audits.
  • Presides over internal and external audit commitments, ensuring sustainable compliance.
  • Maintains, analyzes and develops plans for improving quality metrics for Supplier Quality and Auditing Programs.
  • Stays current and is an internal subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
  • Supports regulatory inspections as necessary.
  • Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality Control, and Facilities Engineering.
  • Ability and willingness to work in a fast-paced environment
  • Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control.

Education & Experience:

  • Bachelor’s degree in biological science or technical discipline. 
  • Minimum 7+ years’ experience in GMP pharmaceutical, biologics and/or vaccine manufacturing.
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.
  • Knowledgeable of FDA and EU regulations regarding the manufacture of biologicals including regulatory inspection experience.
  • Knowledge and experience in auditing Drug Substance manufacturing, Formulation/Fill finish manufacturing, and Material suppliers.
  • Excellent multi-tasking, analytical, organizational and leadership skills.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Proficient in Window based software to include Excel and Word. Ability to adapt to changing software programs.
  • Ability to communicate clearly and effectively with all levels of the organization.
  • Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.