This position provides technical leadership and accountability for computer system validation of R&D Systems to ensure compliance with internal and external computerized system policies and regulations. As the Subject Matter Expert, this individual will be responsible for promoting current computerized system validation practices with particular focus on impact to patient safety, product quality and data integrity. Position scope includes supporting local and global R&D systems as well as SaaS (Software as a Service) solutions. This role will report into the Associate Director of Validation.
Subject matter expert of validation of Computerised Systems and automated laboratory equipment software and associated business system interfaces.
Lead role within cross-functional project teams representing Validation to ensure projects are completed in line with procedures, regulations and business needs. Measure and report project execution progress.
Responsible for decisions that impacts the project timplementation, solving complex technical problems without compromising compliance/ Regulatory requirements
Complete technical responsibility for defining the directional course on a project area ensuring consultation and communication with impacted team/ individuals/ stakeholders
Performing System based Risk Assessments to ensure validation efforts are directed at the systems that have the potential to impact product quality, efficacy, and data integrity using a variety of tools including GAMP 5 and Quality Risk Management.
Development, review and execution of Validation related documents throughout system lifecycle.
Support Inspection Readiness activities by developing and maintaining Validation Dossiers and providing responses to inspectors/auditors for supported computer systems.
Support Periodic Reviews activities through review of system's Validation documentation and assist in authoring Periodic Review Reports.
Manage and implement Validation corrective actions originating from Periodic Reviews and other transversal processes.
Support Supplier Audits as Validation Subject Matter Expert by preparing agenda, performing the audit and authoring reports with topics pertaining to Computer System's Validation
Prepare materials and deliver Trainings related to Computer System's Validation and other related Processes to ensure the site(s) are compliant with current corporate global computerized validation policies
Deliver relevant trainings to project teams before beginning computerized system validation activities.
Performing Super User duties for Valgenesis system including but not limited to; user management, Periodic Access Reviews, updating Computer system's listings.
Proficiently write or review validation documents and procedures with minimal consultation.
Track record in being decisive in situations including tight timelines - exhibit strength and conviction knowing when to be directive, when to be collaborative and when to escalate.
Provide Validation representation at appropriate working groups and fora as required
Demonstrate an effective and flexible communication style when communicating with the team and cross functionally.
Actively participate in Professional/Industry groups ~ to learn, influence and represent Alkermes.
Basic Qualifications:
Bachelor's degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality orientation.
Minimum of 8-10 years of experience in a high volume commercial / clinical pharma / healthcare facility, with a minimum of 3 years at Management level supporting R&D applications.
Preferred Qualifications:
Experience with Electronic Data Capture System, Trial Master, Data Visualization tools, Clinical Risk Management tools, Medical Inquiry (Medical Affairs), Drug Safety System is a plus.
Knowledge of GxP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11, Part 312, Part 314, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
Excellent interpersonal, leadership, collaborative, communication (written and verbal) and time-management skills are essential.
Proven track record in current and previous roles. Results and Performance driven.
Strong leadership skills and ability to work within cross-functional teams.
Experience leading technical teams is essential.
Flexibility and adaptability to changing needs and work product requirements
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic inf ormation, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.