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Executive Director Quality Systems and Compliance

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 key responsibilities of this position are:The ED/VP Quality Systems and Compliance will provide strong leadership and strategic direction to the entire quality organization across R&D, Plasma, Operations and Affiliate teams. This position will manage, direct and maintain the company's Quality Management System, quality oversight of GxP computerized systems, global internal audit, company wide Risk Management processes and supplier quality management. This position will ensure regulatory compliance of all internal GxP functions and external GxP vendors. This individual will ensure CSL Behring maintains currency with regulatory standards and guidance. There will be a strong focus on the simplification and standardization of our Quality Management System and SOPs to improve compliance and efficiency.The incumbent will have demonstrated strong technical knowledge and cGxP compliance as it relates Quality Management System and internal audit and compliance. The individual will have a track record of implementing productivity improvements through digital technologies and systems simplification and standardization.Key member of the CSL Behring Quality Leadership Team and will be an influencer at senior levels within CSL Behring. Key interface with Global Regulatory Affairs,QualificationsThis position reports to: Global Head of QualityReporting to this positionHead of Quality Management SystemsHead Internal Audit & ComplianceHead of Risk ManagementHead of Supplier QualityHead of Digital Quality (formerly BT Quality)1.Establish and manage a standardized enterprise wide Quality Management System and sustain and improve this system when required.Review, rationalize, redesign, and implement the CSL Behring Quality Management System (QMS) to meet global GxP compliance requirements, industry standards and business needs.Ensure implementation of the QMS across the networkDevelop and implement quality risk management tools and principles to improve quality, compliance and GxP decision makingSet up and oversee an enterprise wide QMS team ensuring standardization across CSL BehringOversee specific requirements for R&D QMS and Plasma QMS.2.Establish and manage a standardized enterprise wide Compliance process for CSL Behring covering all enterprise elementsOwn and oversee Quality Management Review process across CSL Behring. Facilitate the Executive Quality Management Review for Senior Management, including preparations, actions and escalations.Prepare materials for Audit and Risk Management Committee and Corporate Annual Report.Track Quality Compliance trends across the enterprise including inspection findings and responses, regulatory notifications and BPDRsTrack and communicate regulatory inspection trends, new regulations and the latest regulatory guidance (i.e. combination products, data integrity, etc.) and coordinate global implementation plans for CSL BehringEstablish standardized processes and structure for Site Compliance teams within CSL Behring.3.Establish and manage the global quality policies, standards and procedures for computerized systemsEnsure that all aspects of global computerized systems comply with applicable GxP regulatory requirementsDevelop and owns Quality policies, procedures and standards governing GxP computerized systems and ensures compliance to relevant regulations such as Data Integrity standards, 21 CFR Part 11, PIC/s Annex 11, etc. Develop and implement computerized system validation strategy, quality oversight and guidance for all GxP computerized systems implemented. Provide quality oversight of digital quality changes at the local and global level4.Directs the preparation and execution of internal and audit/inspection program to verify compliance with global GxP regulations and corporate requirementsOrganizes and executes internal audits across Operations - including R&D, Affiliates and CSL Plasma when required.Assure sustained, effective implementation of actions to enable complianceTracks key audit performance metrics and participates in periodic reviews to ensure suitability and effectiveness of the Quality audit program.5.Execute and the quality supplier management programEstablish, maintain and execute the company's quality supplier management programSet the strategy, standards, global processes and procedures for supplier introduction, qualification and approvalFacilitate root cause analysis and corrective actions of supplier quality issues and support through his/her team on-site supplier visits for root cause analysis and verification of correction actions of supplier quality issuesCollate and evaluate supplier quality data to identify process improvement opportunities within the supply chainWork with the supplier directly, create correction action plans to address quality failures and issuesDevelop and report on supplier quality Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system6. Develops and leads a cohesive team of senior Quality leaders responsible for consistent standards, systems and quality culture across CSL Behring. Implement efficient and standardized organizational structure for Quality Systems and Compliance across the network. Responsible for the Quality talent development and succession planning. Coach and mentor for key talent.7. Sets and delivers Quality budgets and targets for Quality Systems & Compliance.8. Key member and influencer in CSL Behring Quality Leadership Team. Partners closely with senior leaders in all areas of Quality to achieve standardized systems and compliance across all parts of the operation.Education:Requires a degree in biological, medical, or pharmaceutical sciences or related field (i.e. engineering).A Masters or Doctorate degree desirable.Related Experience:Minimum of 15 years' experience in a pharmaceutical or biopharmaceutical company/ies in roles with increasing responsibility in quality or operations management.Experienced senior quality roles eg Quality Systems, Quality Assurance, Operational Quality, Quality AuditMinimum 10 years of managerial experience Experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up. Extensive dialogue and discussion with regulatory health authorities.Skilled at Quality risk based decision making and able to transfer these skills into teamStrong background in driving out inefficiencies and implementing standardized processes across large networks.Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skillsAbility to build, mentor and grow a high performing and cohesive team of senior Quality LeadersSpecial Training:Ability to work across a range of countries and culturesImplementation of a standardized practices across a networkCompetencies: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.Strategic/Innovative: Global perspective. Takes a broad view when approaching issues. Sees ahead to future possibilities & translates to breakthrough strategies. Collaborates to influence strategies of others, and adapts own strategy towards enterprise value.Change Management:Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to enterprise strategies and direction.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.Capabilities#LI-TD1 #BehringWorker Type:EmployeeWorker Sub Type:Regular

Keywords: CSL Behring, Philadelphia , Executive Director Quality Systems and Compliance, Executive , King Of Prussia, Pennsylvania

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