Altasciences 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.Essential FunctionsQMS Responsibilities
•Responsible for coordinating the overall vendor management function of Altasciences.
•Represent and assist the Director, QMS and Vendor Governance in the coordination of vendor management activities in each stage of the service outsourcing process.
•Responsible for supporting department-related projects.
•Responsible for supporting sponsor and/or regulatory inspections as appropriate.
•Responsible for communicating regular status updates on vendor management program.Responsible for ensuring that all phases of the vendor management program are followed:
•Vendor Qualification
– Work with pertinent Department Heads to ensure that vendors are being vetted as appropriate.
o Ensure that all vendor qualification paperwork is completed as appropriate.o Ensure vendors are properly classified based on their risk profile.o Work with designated Quality Assurance staff to ensure all applicable vendors are audited as appropriate (based on the vendor’s risk profile)
•Vendor Management
– Work with Department Heads to ensure that vendors’ quality and scope of service offering is being monitored.o Serve as a liaison to the Department Heads to ensure that vendor performance evaluations are reported regularly.o Work with designated QA staff to ensure that vendors are appropriately re-qualified as applicable.
•General Vendor Management Responsibilities
– Serve as the primary lead for vendor management-related issues:o Maintain a list of approved vendors for the entire company.
This list should be up-to-date and inclusive of vendors’ status, scope of services for which the vendors are qualified, who the vendor owner is, etc.o Serve as the primary contact for vendor quality issue escalation.o Maintain a vendor profile which is centrally located in the Quality Management System (Master Control).
o Ensure all vendor quality issues are appropriately tracked and trended.o Provide vendor-related quality metrics on a periodic basis.o Serve as Lead-Auditor for vendor qualification audits when possible and/or designate the responsibilities to other designated QA staff when appropriate.Communication Internal: Intra and inter-departmental & inter-site interactions.External: Sponsors, Vendors and Regulatory AgenciesQualifications Educational:Bachelor’s requiredSkills: Demonstrates strong analytical and problem solving skills.
Thorough knowledge of applicable regulatory requirements.
Detail oriented and organized.
Ability to meet tight timelines.
Excellent communication and interpersonal skills, including the ability to liaise successfully with operations team, investigators, vendors, client and regulatory representatives.
Good computer skills and able to learn new technology as needed.
Demonstrates verbal and written skills in communicating regulatory and technical information.
Expertise knowledge of GxP required.Exceptional organizational and leadership skills, quality assurance knowledge.Software: Microsoft Office, Outlook, Master Control.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.Altasciences is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.Altasciences uses E-Verify to confirm the employment eligibility of all newly hired employees.
To learn more about E-Verify, including your rights and responsibilities, please visit www.E-Verify.gov.
Other details Pay Type Salary Travel Required No Travel % 0 Telecommute % 100 Required Education Bachelor’s Degree Apply Now