Director, Quality Control
NewAmsterdam Pharma Corporation
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
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