Quality Assurance Manager / Sr. Manager
Cerus Corporation.
Cerus, US
3d ago

Job Brief (Primary Responsibilities)

Responsible for assuring compliance with regulatory requirements (FDA, MDD, MDR) and ISO standards, with a focus on commercial support

Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD, MDR) and ISO standards, with a focus on commercial support.

Will provide GLP, GMP, and ISO 13485 compliance support as necessary.

Primary Responsibilities :

  • Support Post Market Surveillance activities, including responding to product complaints and commercial product quality issues, preparing customer-facing communications, and performing data trending and reporting analyses as required.
  • Support supplier management program, including performing supplier quality audits and evaluations, interacting with suppliers on quality matters, implementing process improvements, and establishing / revising quality agreements.
  • Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
  • Act as Quality lead on commercialization project teams.
  • Provide risk assessment expertise for internal projects and processes.
  • Audit study reports and raw data for compliance with protocols, SOPs and regulations.
  • Identify compliance weaknesses and ensure the implementation of workable solutions. Communicate compliance requirements at all levels.
  • Write / revise / review SOPs / INSs, prepare flow charts and other quality documentation, including investigation reports, audit reports, quality metric trend reports, etc.
  • Provide training and guidance in the areas of government regulations to effected employees.
  • May participate in and / or represent Quality Assurance on project teams within defined projects.
  • Perform other related duties as required.
  • Qualifications / Requirements / Skills :

  • Bachelor’s degree or equivalent in a scientific discipline with a minimum of 8 years’ experience in a pharmaceutical or medical device industry or Master’s Degree with a minimum of 5 years’ experience.
  • Minimum 3years’ experience in GLP or GMP operations.
  • Strong understanding of the FDA, GLP and GMP regulations and ISO 13485; GCP experience is a plus.
  • Ability to exercise independent judgment.
  • Strong data review and technical writing skills.
  • Direct experience with auditing techniques and evidence development.
  • High-level understanding of scientific approach and analytical thinking of others.
  • Strong communication skills (encompasses verbal, written, interpersonal, listening).
  • Ability to influence others.
  • High level of attention to detail and accuracy; very observant in order to audit properly.
  • Flexible; ability to adapt to changing priorities.
  • Excellent time management skills (schedules, timelines, task prioritization).
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