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Lead Quality Assurance Strategist

2 months ago

Pennsylvania, United States EPM Scientific Full time

Key Responsibilities:

  • Oversee Quality assurance for analytical method validations.
  • Ensure Quality oversight for product release and stability assessments.
  • Manage Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs) to guarantee adherence to regulatory requirements and internal Quality Agreements.
  • Collaborate with CMOs/CLOs to maintain compliance with Quality Management Systems.
  • Accountable for the Quality standards and operational compliance of CMOs/CLOs.
  • Ensure the Quality of products produced, released, and tested at CMOs/CLOs.
  • Set performance targets for CMOs and ensure they are achieved.
  • Address cGMP deviations and investigations, ensuring that appropriate corrective and preventive actions (CAPAs) are executed at CMOs/CLOs and internally.
  • Evaluate Change Requests from CMOs.
  • Contribute to the design, development, implementation, maintenance, and enhancement of Quality Assurance systems and programs to support and manage quality initiatives at CMOs/CLOs and within the organization.
  • Lead or engage in cross-functional project teams as necessary to fulfill quality and business objectives.

Qualifications:

  • Bachelor's degree or higher.
  • A minimum of 10 years of experience in Quality Assurance.
  • Strong understanding of Good Manufacturing Practice (GMP) regulations.
  • Experience in Quality oversight of analytical methods.
  • Familiarity with Quality Systems, particularly in the creation and revision of Standard Operating Procedures (SOPs).
  • Exceptional written and verbal communication skills, with a proven ability to effectively communicate within project teams, departments, and with external partners.
  • Innovative problem-solving abilities and skills in influencing peers.
  • Knowledge of biologics product testing and ICH guidelines for analytical methods is advantageous.

Contract Details:

  • Contract Length: 12 months.
  • Full-time position, 40 hours per week.
  • W2 employment only.