Senior Quality Assurance Specialist / Quality Assurance Manager | CMC
Our Quality team is growing, and we are looking for an agile and enthusiastic Quality Assurance professional with experience in successfully executing on Quality initiatives. Reporting to the Sr. Director, Quality Assurance, CMC, this newly created position will support quality aspects of GMP manufacturing, testing, packaging, labeling, and distribution of clinical trial materials at external vendors. They will also play a critical role in internal quality initiatives and the quality management system.
Constellation is entering late-stage clinical trials and preparing for commercialization and launch of its lead product candidate. We are #BrighterTogether
How You Will Spend Your Day:
- Support the CMC team by performing a variety of quality assurance activities to ensure compliance with Constellation’s Standard Operating Procedures (SOPs) and applicable regulatory requirements
- Review and approve external vendor GMP documents which include but are not limited to drug substance and drug product batch records, packaging and labeling records, specifications and change controls
- Perform product disposition
- Review and approve GMP investigations which include but are not limited to Out of Specification (OOS), Deviations and Complaints.
- Review and approve external vendor analytical documents including method qualification/validation protocols, reports, methods, and stability documents.
- Work closely with internal and external QA and CMC team members on multiple programs through all phases of drug development
- Review CMC sections in regulatory applications
- Ensure documents and records are kept in compliance with Constellation SOPs and applicable regulations
- Assist in maintaining the quality management system
- Other responsibilities as assigned by Quality Management
Key Things About You:
- You will offer a minimum of 5-7 years of experience working in Quality Assurance in a Biotech or Pharmaceutical FDA regulatory industry
- Experience with small molecule and solid oral dosage forms
- Working knowledge of cGMPs, ICH, and applicable international regulations and guidelines
- Strong understanding of phase appropriate cGMP requirements
- Oncology experience is preferable
- Ability to work in a fast-paced virtual manufacturing environment
- Strong communicator both written and oral
- Attention to detail
Don’t see the position you’re looking for? We want to hear from you regardless! Please submit your CV to us at firstname.lastname@example.org
Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.