What are the responsibilities and job description for the Senior Manager, Analytical Quality Assurance position at Digital Prospectors?
Job Title: Senior Manager, Analytical Quality Assurance
About the Role:
This is a highly motivated and experienced Senior Manager position for the Analytical Quality Assurance (QA) team. The role will support quality control activities in early and late-phase clinical, as well as commercial stage development and production. The Senior Manager will work closely with cross-functional teams including CMC Quality Assurance, Analytical Development, CMC Quality Control, and other departments involved in the development of biologics and small molecules.
Key Responsibilities:
Requirements:
About the Role:
This is a highly motivated and experienced Senior Manager position for the Analytical Quality Assurance (QA) team. The role will support quality control activities in early and late-phase clinical, as well as commercial stage development and production. The Senior Manager will work closely with cross-functional teams including CMC Quality Assurance, Analytical Development, CMC Quality Control, and other departments involved in the development of biologics and small molecules.
Key Responsibilities:
- Provide QA oversight for analytical method lifecycle activities, including development, validation, transfer, verification, performance monitoring, and documentation.
- Support change management processes and lead investigations for deviations, OOS, OOE, and OOT events.
- Review CMC-related regulatory documentation to ensure compliance with FDA, EMA, ICH guidelines, and internal policies.
- Collaborate with cross-functional teams to establish quality agreements with contract testing laboratories and contribute to root cause analysis and risk assessments.
- Ensure all activities meet regulatory requirements and industry best practices while supporting both pre-clinical and commercial product development.
Requirements:
- Bachelor's degree or equivalent experience in Quality Control or a related field.
- Minimum of 1 year of experience in QA and at least 5 years of experience within a regulated industry (CBER/CDER), with expertise in cGMPs.
- Experience supporting analytical development and QC in biologics and small molecules.
- Proven experience managing relationships with contract testing labs and Contract Manufacturing Organizations (CMOs).
- Strong interpersonal skills with the ability to collaborate effectively within a team environment.
- Excellent analytical and systematic thinking skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Familiarity with Electronic Quality Management Systems (eQMS), such as Veeva, is required.
- Experience establishing quality agreements with contract testing laboratories is a plus.
- Knowledge of statistical tools for data analysis and trending is highly desirable.
