Director of Quality Assurance | CMC
Who we are:
Constellation Pharmaceuticals is a pioneering epigenetics company, focused on the discovery and development of novel, small molecules targeting chromatin regulatory proteins in tumor and immune cells for therapeutic applications in oncology. We believe that each team member has the ability to impact and improve the lives of patients. We are #BrighterTogether.
How you will spend your day:
This newly created role will establish and maintain oversight of internal quality systems as well as oversee quality aspects of manufacturing, packaging, labeling, and distribution of clinical trial materials at external vendors. The QA Director will manage CMC Quality activities in accordance with GxP principles and applicable Quality and regulatory guidance in a phase-appropriate manner. This role will include the identification of GxP risks along with the development of remediation plans and continuous quality improvement initiatives. The QA Director will lead audits and manage health authority queries and inspections.
- Establish Quality Management Systems in compliance with regulations through the management of quality systems and standards.
- Effectively interact with internal team and manage all third parties contracted to perform GMP manufacturing activities to ensure full compliance and adherence to timelines.
- Perform batch release activities and review reprocessing and rework procedures.
- Oversee GMP testing to assure conformance with protocols, policies and GMP regulations.
- Develop and maintain internal SOPs.
- Plan and conduct audits and inspection readiness of manufacturing and release sites.
- Initiate continuous improvement activities, create/revise procedures/practices and specifications, and provide training on quality systems and procedures.
- Manage product complaints and investigations for clinical supplies.
- Serve as subject matter expert, keeping current with GxPs and industry practices, in order to provide organizational support.
Key things about you:
- BS, MS or Ph.D. degree in a scientific or health-related field (advanced degree highly preferred)
- A minimum of 10 years of experience in regulated biotechnology or pharmaceutical fields
- 4 years of experience in GMP Quality environments
- You will be a knowledge expert in the areas of GMP and QA principles, practices, and standards
- You will also have experience with health authority GMP inspections and expectations relating to pharmaceutical quality/CMC
Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.