Jan 25, 2020
Job Description Responsible for contributing to key functional, tactical, and operational aspects of the Global Stability group at Biogen. Ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and FDA guidelines. Provide technical expertise and leadership for the stability program of commercial/clinical products. This includes design of stability protocols, maintaining data, expiry dating for products, authoring stability sections for submissions, technical assessment of stability specification changes and stability investigations. Proficient in understanding of Quality Systems and apply knowledge in coaching and continuous improvements of systems cross-functionally. Ensuring adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key customers. Provide technical support during audits/inspections. Able to work effectively, independently and within a team framework, across all business areas and levels of the organization. This requires excellent written and verbal communication skills. Delegated owning department signature authority for stability documents. Design and manage studies. Independently author stability protocols and collaborate with Sample Control and QC laboratories to ensure proper testing and reporting of stability samples. Manage moderately complex issues, barriers, problems to support team success. Possess thorough knowledge of methods for data trend analysis and stability data behavior. Perform technical review of complex analytical data, interpret data and author in-depth technically-sound stability reports/regulatory submissions independently. Provide technical leadership through effective project management, status tracking, data analysis, presentations, and communication. Approve data/reports for team in the area of discipline/focus. Participate effectively in a leadership or membership role for site cross-functional teams as a representative of the Global Stability organization. Actively provide leadership and mentoring as needed to aide in the development of team/peers, self and team projects. Rrepresent department in internal and external audits proficiently. Author response to regulatory questions with minimal oversight. Approves at area manager level documents authored by other colleagues through delegation authorized by this document - including/not limited to: supplemental sample request forms, stability protocols, stability/expiry reports for DS/DP/RS, clinical expiry certificates, stability transfer reports, and annual product review stability reports Contribute to major/critical manufacturing and lead stability investigations (deviations, OOS, cross-site and cross-functional). Independently author stability assessments for Anomalous Results (ARs) and Out of Trend (OOT) stability results. Alert Quality organization about potential issues and evaluate remedial actions. Provide innovative solutions to unique complex problems. Proactively identify technical gaps and areas for improvement related to quality or process and lead them through completion. Participate on Asset sub-teams and maintain thorough knowledge of CMC program for assigned products. Collaborate routinely with other line functions and sites as well as internal/external partners and lead cross-functional teams. Qualifications Advanced knowledge of operations/quality systems/directives and apply the knowledge within the team/project management routinely. Excellent technical writing, presentation and oral/written communication skills. Author technically sound and highly complex reports, and approve data/reports. Provide leadership for complex situations/issues problem solving to effectively reach solution. Mature leadership approach and understanding of their personal communication style and manage that effectively. Accountable for measurable goals/targets in work area. Possess strong organizational skills with ability to multi-task and coordinate multiple activities in parallel. Good knowledge of FDA/EMA regulations and compliance. Mentor junior members of team in quality systems, process improvements. Formulate solutions/options for team and reach out extennally to regulatory/global teams for alignment. Conduct impact assessment related to compliance (e.g., global directives, audit finding/readiness, deviations). Leadership competencies include: Personal Drive, Decision Making, Communication, Building Strategic Work Relationships and Innovation. Education: BA/BS in Life Sciences with 10+ years of relevant industry experience, or MA/MS in Life Sciences with 7+ years of relevant industry experience, or Ph.D in Life Sciences with 5+ years of relevant industry experience. Additional Information All your information will be kept confidential according to EEO guidelines.
Professional Diversity Network
Research Triangle Park, Durham, NC, USA