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Director, Engineering Commissioning & Qualification

Company: CSL Behring
Location: King Of Prussia
Posted on: May 23, 2020

Job Description:

With operations in 35+ nations and - 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus.CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operatesCSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!ResponsibilitiesThe Global Owner of Commissioning & Qualification role is accountable for developing a global center of excellence for verification/commissioning and qualification based on CSL Behring engineering standards, current regulations, industry standards and industry practices for biopharmaceutical facilities. This leader will be responsible for oversight and management of the verification/commissioning and qualification life cyscle across a global portfolio of engineering capital investments being executed by internal and external resources. This role will have a wide focus requiring an understanding of how to integrate the activities of numerous areas of technical, operational, and business expertise and align them toward accomplishing common goals.QualificationsPrincipal Accountabilities:1Develop and maintain a global center of excellence with best practices, strategies and framework for commissioning and qualification based on current regulations, industry standards and industry practices for biopharmaceutical products.Promote innovative and efficient approaches to C&Q incorporating risk-based elements and considerations unique to biopharmaceutical production. Develop and implement risk management tools and techniques to ensure the appropriate prioritization and level of rigor to qualification activitiesThrough collaboration with process experts, apply a science-based approach to qualification with an understanding of how the systems and equipment enable and control the process.Apply Lean Six Sigma approaches to drive efficiency in C&Q by establishing practices that enable identification and elimination of waste.Review and approve C&Q master plans and reports for systems and facilities, in collaboration with the quality and technical SME network. Review supplier Quality Systems and documentation supporting C&Q and develop strategies to assess any gaps or risksResponsible for C&Q Standards applicable across the US/EU/APAC networkPartner with Quality Unit Peers to align on requirements for Procedures and Standards. Facilitate collaborative sessions to align on attributes to meet requirements.Identify opportunities to standardize processes such as global SOPs and implement and oversee training to achieve cultural change.Collaborate with QA to develop a framework to manage change control impacting C&QEstablish a high-performing team that can provide expertise for deviations, CAPAs, audit observations related to C&Q work, strategy and methodologies.Track performance metrics and provide progress reports to senior managementLead global C&Q team providing oversight of internal programs and with direct responsibility for C&Q activities related to CSL product transfers to contract manufacturing organizations, including gaps assessments during CMO selection and facility fit assessmentsDesign qualification strategies to support novel applications with CSL's manufacturing network and technologies2Management:Directly oversee staff at multiple international sites. Responsible for development of staff, including motivating in a manner that promotes the achievement of CSL's business goals and objectives.Establish performance goals and strategic/operational objectives for direct reportsCoach, counsel, and appraise performance of personnel.Develop staff competencies & capabilities to enable sustained success and career developmentPromotes high employee engagement and a positive work environment.Responsible for organizational design, resource requirements and staffing decisions. Recruit, retain, train and develop the team.Education:Undergraduate degree in Engineering or other related technical field. Graduate degree preferredRelated Experience:10+ years working in GMP commissioning and qualification with 5+ years of experience in biopharmaceutical facilities and systems.Demonstrated experience in managing a multi-layered department across multiple international locations.Strong communication, negotiation and conflict management skills to influence technical experts and stakeholders at all levels in the organization.Demonstrated experience in managing, organizing, developing and deploying best practice frameworks, processes, tools and templates.Special Training:Lean Six Sigma training/certification is a plus.Competencies:Proven leadership, organizational and interpersonal skills by demonstrating the following competencies at the enterprise level:Customer Orientation (Internal/External):Creates companywide strategies to stay ahead of industry-related changes. Drives alignment across the enterprise in order to serve customer needs. Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs.Enterprise Results and Value Orientation: Looks for outcomes that maximize the benefits for the enterprise, not just their department or function. Pursues value realization for the enterprise even if their function does not benefit.Collaboration and Influencing:Champions a culture of inclusiveness and teamwork.Collaborates effectively with others and influences all stakeholders towards enterprise outcomes. Embraces conversations needed to deliver enterprise value.Priority Setting: Spends his/her time and the time of others on what's important; quickly zeros in on the critical few and puts the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.Problem Solving, Creativity and innovation management:Uses rigorous logic and methods to solve difficult problems with effective solutions, can see hidden problems, is excellent at honest analysis.Interpersonal Savvy: Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.CapabilitiesWorker Type:EmployeeWorker Sub Type:Regular

Keywords: CSL Behring, Philadelphia , Director, Engineering Commissioning & Qualification, Executive , King Of Prussia, Pennsylvania

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