Director, Quality Control

NewAmsterdam Pharma Corporation

Director of Quality Control overseeing compliance in pharmaceutical QC tasks and vendor operations. In charge of analytical methods and regulatory submissions related to quality control.

Posted 4/15/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

analytical testing methodsdata integritymethod validationmethod verificationquality controlGxP standardssmall molecule drug substance testingnon-sterile oral solid dosage testingregulatory submissionsquality metrics analysis

Soft Skills

verbal communicationwritten communicationcollaborative problem-solvinganalytical skillsindependent workcross-functional teamworkrelationship managementadaptabilityprioritizationminimal supervision