Harleysville, PA 19438, USA
Monday, April 18, 2022
is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Job Title: QA Manager
Department: Quality Assurance CDMO
Primary Responsibilities: Manages QA staff and resources to ensure efficiency across functions and sites.
Responsible for staff development and align with strategic plan needs.
Integrate internal and external quality information to quickly adapt and modulate QA activities.
Application of risk assessment approaches within QA operations.
Lead the coordination and logistics of sponsors and/or regulatory authorities inspections.
Ensure QA operations consistently meet internal and external timelines.
Second level of quality issue escalation / conflict resolution.
Maintain and monitor Key Performance Index related to QA pertinence and timelines.
- Approve the annual internal audit program and ensure they are adequate and reflective of the needs identify from risk.
- Identify and coordinate training within the group.
- Author responses to regulatory agency and/or sponsor's audit findings to ensure they are adequate, complete, compliant, and appropriate.
- Prepare annual staff development plans, and provide resources towards their completion.
- Integrate quality inputs from the other departmental managers
- Provide quarterly quality reports to senior management, on initiatives, risk assessment approaches and results.
Education: Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field with a minimum of ten years experience, or equivalent combination of education and experience, in the pharmaceutical industry.
Strong knowledge and understanding of US, Canadian and EU GMP Regulations and guidelines.
Project management and coordination skills.
Ability to meet tight deadlines.
Tactful, reliable, persuasive, dependable, consistent, flexible.
Good written and oral communication skills
Skills in software applications including Microsoft Office, QMS, and inventory management systems.
Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.