YOUR NEW COMPANY!

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.
We are better together and together We Are Altasciences.

ABOUT THE ROLE

Supervises and is responsible for providing Quality Assurance (QA) oversight, collaboration and review of Computerized System (CSV) Lifecycle validation deliverables and leading corporate Data Integrity initiatives for GCP, GLP and GMP programs as specified in company protocols and SOPs. Supervises and directs Quality Assurance (QA) staff.

WHAT YOU’LL DO HERE

• Acting as subject matter expert for QA in CSV and data integrity.
• Provide Quality oversight, review and audit of CSV and equipment validation documentation.
• Develop training programs and provide training for team members.
• Represent all sites regarding QA CSV in meetings.
• Lead and manage initiatives related to CSV and data integrity.
• Support client audits, computer system vendor qualifications and audits, and regulatory inspections.
• Provide QA support and input to enforce CSV and Data Governance guidelines, policies and procedures.
• Optimize CSV auditing processes throughout all sites.
• Assist with revision or creation of SOPs, policies as well as QA tools and templates, with related training, related to CSV and Data Integrity.
• Responsible for overseeing the development of QA auditing guides and tools for validated systems.
• Ensure that the Computerized System Validation Lifecycle efforts are in compliance with 21 CFR Part 11 and applicable FDA/EMA Guidance on electronic data integrity.
• Participate in site, business unit, and corporate quality and process improvement initiatives related to CSV and Data Integrity as needed.
• Communicate all identified compliance and quality risks to management.
• Conduct data integrity risk assessments and consult in risk mitigation strategies as needed.
• Responsible for staff development.
• Ensures the regulatory trends in the industry are transposed, communicated and transferred to the QA staff.