NewAmsterdam Pharma Corporation logo
NewAmsterdam Pharma Corporation

NewAmsterdam Pharma Corporation is a clinical-stage biopharma company creating therapies for cardiometabolic diseases.

Director, Quality Control

Location

United States

Posted

65 days ago

Salary

0

Seniority

Lead

Bachelor Degree8 yrs expEnglish

Job Description

Director, Quality Control

NewAmsterdam Pharma Corporation

• Responsible for managing the Quality Control tasks and reports into the NAP Quality Team. • Review CMO QC laboratory operations, ensuring compliance with regulations such as FDA, EMA, Health Canada, and Rest of Work regulatory requirements as well as Global regulatory and ICH guidelines. • Support analytical development in a quality role; ensuring data integrity; creating, reviewing and approving technical documents (such as stability reports, method validation and method verification protocols and reports and final analytical release data). • Analyze data and metrics relate to quality control to identify trends, patterns, and areas for improvement. • Establish and maintain relationships with suppliers and vendors to ensure compliance with quality control standards. • May be a subject matter expert for regulatory submissions and inspections related to Quality Control tasks and data.

Job Requirements

  • Bachelor's degree in a Chemistry or similar scientific discipline, advanced degree preferred
  • 8-10 years in the pharmaceutical industry working in QC
  • Strong understanding of analytical testing methods and records
  • Deep understanding of GxP standards, policies, and procedures (domestic and international)
  • Experience and strong understanding of small molecule drug substance and non-sterile oral solid dosage drug product testing
  • Experience working with CDMO/Contract manufacturing and contract laboratories.
  • Excellent verbal and written communication skills
  • Collaborative problem-solver, ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
  • Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision
  • Ability to travel domestically and internationally, approx. 10-15% of the time
  • Proficiency is using quality control tools and software, such as statistical analysis software, quality management systems and AI.

Benefits

  • Health insurance
  • Dental and vision coverage
  • Term life and disability coverage
  • Retirement plans
  • Stock option awards

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