Senior Director, Plasma Quality Assurance

The OpportunityYou will be responsible for all phases of Plasma Center Quality. Directs Regional Directors of Quality and Sr. Manager of Quality, other Managers' activities to ensure quality, regulatory requirements, customer requirements are met while managing other performance metrics. Always ensures donor and employee welfare and safety. Collaborate with Division Director of Plasma, peers, and global quality leaders to develop, deploy and manage CSL Plasma Quality performance and provides oversight to ensure compliance is at the expected levels. The Senior Director, Quality Assurance is a member of Plasma Quality leadership team, Operational Leadership team (OTL), Quality risk management and extended Global Quality Leadership Teams. This position determines and executes the strategic vision, goals and direction for Global Plasma Quality for US, US territories, Latin America, Plasma Centers and US Laboratory Services quality. This position reports to the Global Head Plasma Quality.The RoleLead the field quality team to deliver on quality KPI metrics as defined by CSL Plasma and CSL Behring in partnership with Quality and Operational Regional Leads, supports the establishment and maintenance of high-quality working relationships with the FDA, EMA, and other global regulatory agencies.The Sr. Director of QA is accountable for the delivery of successful regulatory license inspection outcomes of centers and US laboratories including new center pre-licensing and requalification inspections. Develops quality and resource plans that meet KPI metrics and Identifies and evaluates fundamental issues for fleet through assessment of intangible variables and works on abstract problems across functional areas of the business.Responsible for setting and implementing the overall center performance quality objectives. This includes but is not limited to employee development and succession planning, safety, quality standards including audit readiness and performance.Direct quality plasma operations and partner with senior leaders to ensure adherence with quality systems standards to identify, review and establish plans to eliminate risk associated with quality and safety non-compliance. Establishes and implements an effective SOP system to support compliance and auditing to support quality systems that comply with federal, state, local and industry guidelines.Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Balances corporate demands with field responsibilities. Interacts internally and externally with executive-level management requiring negotiation of extremely difficult matters to influence policy-making bodies both internally and externally. Manage successful negotiations with external auditors or other regulator representatives.Acts as the primary quality resource within CSL Plasma for specific projects, the position will have responsibility for ensuring collaboration with key internal stakeholders of Core Project Teams (CPT), Safety Management Team (SMT) Operational and Development teams to ensure the plasma quality strategy is an integral component of stakeholder deliverables.Interprets and set strategic direction that proactively and productively addresses regulatory expectations for US, US territories, Latin America fleet of sites.  Work with leadership to leverage existing forums to achieve oversight objectives effectively. Develop quality strategic plans aligning business plans with global CSL policies to maintain audit-ready and compliant state operations for all sites considering relevant regulations and customer requirements.The Dir., Sr. GPQ is a company resource for global quality perspective and drives the Quality Culture perspective within the company. Responsible for Directing teams within the plasma quality environment and implementing successful global quality strategies.Direct quality leadership team; ensure policies, capabilities, capacities and initiatives align within assigned areas to meet strategic business needs.  Assess business process improvements opportunities to increase productivity and robustness.  Participate in quality resource utilization priorities setting to ensure quality and management input participation for required projects.Act as the CSL Plasma quality representative in cross-company CSL global quality system programs, projects, and other global initiatives.Develop and maintain a broad understanding of our business processes and core competencies that drive our success.  Think and act strategically in collaborations with colleagues, and multiple stakeholders, across geographies, seeking to optimize performance and compliance outcomes for the company.  Motivate and develop staff and peers to drive performance towards compliant productivity gains, viewing reduction of scrap and rework amongst indicators of quality. Collaborate with Regulatory and Operations to develop suitable responses to regulatory changes and shifts in expectations, especially as it relates to lab and IT infrastructure and software.  Collaborate with suppliers to recover supply or services during supplier disruption or quality issues to maintain stable operations.Apprise executive management of emergent situations capable of disrupting operations; and work diligently to avoid such disruptions by collaborating with operational leaders, as applicable.  Troubleshoot externally during an audit or inspection while interacting with critical suppliers and various regulators.Participate, and set direction in regulatory audits when a challenge to our procedures would result in a risk to business continuity, as applicable. Direct staff, including selecting, training, developing, coaching and terminating, as applicable with guidance from Human Resources.  Appraise employee performance and provide feedback and counseling to staff, as applicable.  Develop succession plans and oversee immediate staff career development. Develop and manage multiple departmental budgets to the annual budget designed to meet or exceed objectives by continuous review of performance against KPIs.Maintain frequent and open communications with executive and corporate leaders that focuses on timely resolution of issues that may potentially affect the safety, quality, identity, purity and/or potency of collected plasma.  Provide timely documentation of defined GxP processes performance.Review and approve quality policies and procedures for areas of responsibility.Perform other duties as assigned to support business needs.Overnight travel required up to 50% of the timeYour skills and experienceEducationBachelor's degree in relevant sciences, industrial engineering or quality management preferred, or equivalent combination of education, training and experience.Advanced degree in related areas or business is preferred.Educated and skilled in the use of risk based analytical tools and lean manufacturing process development, such as six sigma.ExperienceMinimum 10 years successful leadership experience managing operational or quality teams to deliver results in a dynamic, high growth environment requiring creativity and stamina.Understand regulatory standards, various local, state and federal laws that apply to the business and where to find information on standards and interpretations in more than one key region (i.e., EU, US, Latin America, Japan and ROW)Experience interfacing with regulatory agencies, including leading and preparing the organizational team for an interaction.Experience in leading and managing matrix teams (minimum 5 years), setting clear direction, holding people accountable and fostering a collaborative team environment.Experience establishing solid working relationships to interface and support all functional areas of the organization, senior management, third parties as well as other related groups, agencies, customers, suppliers and circumstances within the organization.Computer literate with proficiency in office applications and use of electronic quality and operational systems including statistical process control and database query tools such as Trackwise, Master Control DTAC, Plateau, Logic, StarLIMS.Working Conditions (physical and mental requirements)Ability to make decisions which have significant impact on the Company's creditability, operations and servicesAbility to formula complex and comprehensive materials such as authoritative reports or major scope and impact, etc. and/or to make formal presentationsFrequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogensRequired to wear Personal Protective Equipment while performing specific tasks or in certain areasFrequent standing and walkingAbility to lift or carry up to 25 lbsFast-paced environment with frequent interruptionsOur BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.  For more information on CSL Plasma benefits visit CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.Do work that matters at CSL Plasma!

Created: 2025-03-04