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Lead Quality Assurance Strategist

2 months ago

Pennsylvania, United States EPM Scientific Full time

Key Responsibilities:

  • Oversee the Quality assurance of analytical method validations.
  • Ensure Quality oversight for product release and stability assessments.
  • Manage Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs) to maintain adherence to regulatory standards and internal Quality Agreements.
  • Collaborate with CMOs/CLOs to uphold Quality Systems compliance.
  • Accountable for the Quality benchmarks and operational status of CMOs/CLOs.
  • Ensure the Quality of products produced, released, and evaluated at CMOs/CLOs.
  • Set performance targets for CMOs and guarantee achievement of these objectives.
  • Address cGMP deviations and investigations, ensuring that suitable corrective and preventive actions (CAPAs) are executed at both CMO/CLO and internal levels.
  • Evaluate Change Requests from CMOs and contribute to the design, development, implementation, maintenance, and enhancement of Quality Assurance systems and programs to facilitate and oversee quality activities at CMOs/CLOs and within the organization.
  • Lead or engage in cross-functional project teams as necessary to fulfill quality and business objectives.

Required Qualifications:

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

Contract Details:

  • Contract Length: 12 months
  • Work Schedule: 40 hours per week
  • Employment Type: W2 only