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Executive Director, Technical Services

GENERAL SUMMARY: The Executive Director, Technical Operations is responsible for the oversight of the technical organization at the site. The primary responsibilities of the Executive Director is leadership of the team that executes and provides oversight of production process performance, process validation and technical transfer, sterilization and cleaning validation, change implementation, and deviation investigations and CAPA implementation among other related duties. GENERAL PROFILE: Manages leaders of professional technical teams Represents Technology at the divisional leadership level within Tech Ops and on the site leadership team Accountable for performance and results of the department, site and division Executes functional business plans and contributes to the development of group or country strategies Decisions are guided by group or country strategies and policies; creates and approves new guidance Leverages relationships with key clients and/or customers to support business needs Adapts departmental and site plans and priorities to address resource and technical/operational challenges Provides technical guidance to employees, colleagues or clients  Anticipates and interprets client and/or customer needs to identify solutions BUSINESS EXPERTISE: Applies management and leadership skills to align staff activities with departmental and site objectives Sets business and technical priorities for the technical team and site Oversees strategic and local project portfolio for process oversight and improvement FUNCTIONAL EXPERTISE:  Work with a cross functional organization consisting of Operations, Technology, Quality, Automation, Global Engineering Services, and Regulatory team members, among others, to develop and maintain manufacturing processes that meet cGMP and business requirements.  Utilize core technology principles to design and develop processes to clean, sterilize, manufacture, formulate, fill, lyophilize, and inspect vaccine products. Develop technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstration, process change and validation. Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence.  Ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.  Provide leadership on schedule, priorities, and issue resolution to aid the team in accomplishing business objectives.  Coordinate the work of the technical team to identify and implement technology-driven productivity and cost improvements. Assist in authoring regulatory submissions and presenting work to multiple regulatory agencies throughout the inspection process.  Responsible for building/growing the organization's functional excellence. Recruit and direct engineers and scientists as necessary. Develops technical/professional staff through mentoring, assignment selection and training.  Guides the site strategy portfolio and implementation PROBLEM SOLVING: Directs the resolution of highly complex business or technical problems. IMPACT: Influence: Negotiates with and influences the opinions of others within the division and with clients, customers Communicates information, asks questions and checks for understanding Accountability: Accountable for the performance and results of a department. Decision Making: Makes decisions - guided by division and group strategies - that impact the group or departments STRATEGIC PLANNING: Develops department plans to execute group and division strategy RESOURCE MANAGEMENT: Forecasts resource needs; manages allocated budget WORKING RELATIONSHIPS: Reports to the Vice President of Plant Management. Manages and interacts with employees within own department, across site and across the company Provides technical guidance to site management team Frequent interaction with employees from other departments and sites Interacts with representatives from regulatory agencies Interacts with external suppliers and customers Qualifications Education: B.S. degree in Engineering or Sciences  Required: Minimum 15 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. / PhD degree plus 12 years). Minimum six years of team management experience. Experience in biologics, vaccine or bulk sterile manufacturing facilities. Regulatory inspection presentation experience with external regulatory authority representatives.  Highly developed communication, leadership and teamwork skills.  Experience leading and managing departmental or cross-functional teams Preferred: M.S. degree (or higher) in Engineering or Sciences and/or relevant work experience.  Green Belt / Black Belt Certification ID: CHE006326
Salary Range: NA
Minimum Qualification
15+ years

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