Dynavax Technologies

QA Senior Specialist Supplier Management m,f

DE-NW-Düsseldorf
4 weeks ago
Req. #
HP-213
# of Openings
1
Category
Quality Assurance

PRIMARY PURPOSE OF POSITION

In this role, you will be responsible for the quality management of Suppliers and Service Providers and being part of Quality Assurance organization.

 

To support the success of our team, you will ensure that the function of the Suppliers and Service Providers is appropriately maintained and developed.

MAJOR DUTIES OF POSITION

  • Manage Suppliers and Service Providers Qualification System
  • Develop Suppliers and Service Providers audit schedules and execute the audits. Provide final audit reports and perform follow-ups to open items discovered during audits
  • Review and approval of relevant standard operating procedures (SOPs) and, where necessary, write and/or revise SOPs
  • As requested, provide assistance with all regulatory inspections and any other audits
  • Provide quality assistance to other departments as requested
  • Administer company policies that directly affect unit and sub-units
  • Travel as required to accomplish responsibilities of position

KNOWLEDGE AND SKILL REQUIREMENTS

  • A University degree in life sciences, preferably in a Biology Science, Microbiology, etc. 
  • At least 2 years as auditor and Suppliers quality management for pharmaceutical or food or biotechnological industries
  • At least 5 years of experience in quality operations in the biotechnology or pharmaceutical industry
  • Knowledge of FDA and EU regulatory requirements for biologics and pharmaceuticals
  • Demonstrated track record of success with improvement and maintenance of quality operations
  • Experience with regulatory agencies concerning inspections and questions related to submissions for product approvals
  • GMP knowledge and demonstrated ability to establish standards in support of the quality system
  • Strong analytical and problem solving skills
  • Willingness to travel approximately 20% to support corporate initiates
  • Excellent communication, interpersonal skills as well as organizational skills and attention to detail
  • Proven ability to establish collaborative working relationships; team player and independent worker
  • Excellent ability to prioritize and manage multiple projects and tasks
  • Personal attributes include flexibility, integrity, action and goal oriented
  • Business fluent in German and English

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed