NewAmsterdam Pharma Corporation
Director, Quality Control
Remote - USA, USA · Director
Sponsorship not specified$10k-$15kDetected 27 days ago
RESTStatisticsFDA RegulatoryLeadershipCommunicationGxP
About the role
- Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases.
- Our vision is that people at risk for heart disease can take control of their health and live longer, fuller lives.
- Director, Quality Control Director, Quality Control is responsible for managing the Quality Control tasks and reports into the NAP Quality Team.
Responsibilities
- Approve technical documents like validation reports and batch records.
- Stability program leadership: develop, implement, and maintain a comprehensive stability program in accordance with ICH guidelines.
- CMC and Regulatory Support
- Support the CMC Analytical teams in analytical method transfer to various CDMOs and partners.
- Support preparation of CMC investigational and commercial regulatory submissions by reviewing and approving relevant documents per program timelines and associated HA information requests
- Perform internal and external audits.
- NewAmsterdam is an innovative biotech company with the experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals.
Requirements
- 8-10 years in the pharmaceutical industry working in QC
- Strong understanding of analytical testing methods and records
- 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.
- 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.
- Proficiency is using quality control tools and software, such as statistical analysis software, quality management systems and AI.
- Deep understanding of GxP standards, policies, and procedures (domestic and international)
- 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 travel domestically and internationally, approx. 10-15% of the time
- Remote position, US Eastern work hours expected.
- Salary and Benefits:
- We offer a competitive base salary, commensurate with experience. In addition to the salary, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, retirement plans, and stock option awards
Nice to have
- Bachelor's degree in a Chemistry or similar scientific discipline, advanced degree preferred
Compensation
- We offer a competitive base salary, commensurate with experience.
Benefits
- In addition to the salary, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, retirement plans, and stock option awards
- We offer a competitive base salary, annual bonus, and long-term incentives.
- In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.
- 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.
- Together with cross functional stakeholders coordinate and manage compliance related activities in preparation for Health Authority inspections and support interactions during Health Authority inspections
Equal opportunity
- equal opportunity employer.
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