Lead Quality Assurance Strategist

2 weeks ago


Pennsylvania, United States EPM Scientific Full time

Key Responsibilities:

  • Oversee the Quality assurance of analytical method validations.
  • Ensure Quality compliance for product release and stability assessments.
  • Manage Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs) to uphold regulatory standards and internal Quality Agreements.
  • Collaborate with CMOs/CLOs to maintain adherence to Quality Management Systems.
  • Accountable for the Quality benchmarks and operational compliance of CMOs/CLOs.
  • Guarantee the Quality of products produced, released, and evaluated within CMOs/CLOs.
  • Set performance targets for CMOs and ensure they are achieved.
  • 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 support quality activities at CMOs/CLOs and within the organization.
  • Lead or engage in cross-functional project teams as required to meet 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 overseeing Quality Assurance for analytical methods.
  • Proficient in 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 convey information in a project team setting, within departments, across functional areas, and with external partners.
  • Innovative problem-solving capabilities and strong influence skills.
  • 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


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