Head of Quality, Quality Systems (Cell and Gene Therapy) at Roche in South San Francisco, CA
Job
Summary:
Provide strategic leadership and management to the Cell & Gene Therapy Quality Systems organization within PTQC. Accountable for the establishment and Quality oversight of the global tools, processes and procedures specific to Cell & Gene Therapy clinical development programs. Ensure the Quality tools, processes and procedures used in PTC are fit for purpose, GxP compliant and support Clinical development timelines as well as future commercial launch. Major accountabilities:
Partner with senior leadership within PTQ and PTC to set the strategic direction, goals and objectives to deliver the ATMP portfolio in a compliant manner. Design, hire and lead an empowered team of Quality experts providing quality oversight for a wide range of IT tools, business processes and procedures supporting Cell & Gene Therapy production including, but not limited to, Apheresis collection, AAV plasmid production, Drug Substance manufacturing, Drug Product and Finished Goods manufacturing, analytics for in-process and release testing and shipment to treatment centers. Provide Quality oversight for GxP tools, process and procedures used by the PTC unit. Ensure Quality requirements are phase appropriate and fit for purpose considering the unique aspects of Cell & Gene Therapy production. Provide Quality auditing and certification of Apheresis Centers, patient sample storage and other 3rd party service providers that are technology agnostic. Provide Quality oversight and support for End to End Patient Operations tools, processes and procedures. Ensure alignment with other PTC Quality teams and linkage with the overall Roche Quality and business strategies. Ensure pragmatic, patient-centered problem solving is carried out with a strong sense of purpose and urgency. Contribute to the design and implementation of the necessary Quality standards relevant to Cell & Gene therapy ATMPs within the Roche PQS, in line with applicable international regulations. Foster an environment of continuous quality improvement with a strong focus on process and procedural simplification. Provide leadership to the Quality Systems organization to ensure that teamwork, high morale and innovation are fundamental components of the team. Lead and coach the members of the Quality organization to achieve organizational goals as well as employee personal and professional growth. Develop and maintain an environment of strong collaborations and partnership with internal PTC functions and relevant Roche stakeholders as well as with external partners. Develop annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources. Qualification:
Bachelor's Degree or postgraduate degree in a Life Sciences, Pharmacy, Engineering or related science discipline required. 15
years of experience (or advanced degree
10 years) in the Pharma/Biopharmaceutical industry with experience in aseptic operations, Biologics and ATMPs manufacturing. Experience production gene therapy production and/or analytics is an advantage. 8
years leading teams. Strong knowledge of GxP regulations and how to apply them to clinical and commercial products to guarantee patient safety and ensure the appropriate level of compliance. Agile leader who demonstrates commitment to change, align and help others embracing change. Manages ambiguity through effective communication, removes barriers and overcomes resistance skillfully. Autonomous with ability to manage complex situations successfully as well as to coordinate multiple tasks and manage priorities to deliver on optimum results Demonstrates high integrity and accountability for their area by ensuring team(s) actions and decisions are aligned to business objectives Demonstrates strong collaboration and teamwork skills with a wide assortment of stakeholders from technical/scientific experts to business leaders. Excellent verbal and written communication skills in English, including the ability to present both strategic objectives and tactical actions clearly and concisely May be asked to travel internationally
Salary Range:
$250K -- $500K+
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
Provide strategic leadership and management to the Cell & Gene Therapy Quality Systems organization within PTQC. Accountable for the establishment and Quality oversight of the global tools, processes and procedures specific to Cell & Gene Therapy clinical development programs. Ensure the Quality tools, processes and procedures used in PTC are fit for purpose, GxP compliant and support Clinical development timelines as well as future commercial launch. Major accountabilities:
Partner with senior leadership within PTQ and PTC to set the strategic direction, goals and objectives to deliver the ATMP portfolio in a compliant manner. Design, hire and lead an empowered team of Quality experts providing quality oversight for a wide range of IT tools, business processes and procedures supporting Cell & Gene Therapy production including, but not limited to, Apheresis collection, AAV plasmid production, Drug Substance manufacturing, Drug Product and Finished Goods manufacturing, analytics for in-process and release testing and shipment to treatment centers. Provide Quality oversight for GxP tools, process and procedures used by the PTC unit. Ensure Quality requirements are phase appropriate and fit for purpose considering the unique aspects of Cell & Gene Therapy production. Provide Quality auditing and certification of Apheresis Centers, patient sample storage and other 3rd party service providers that are technology agnostic. Provide Quality oversight and support for End to End Patient Operations tools, processes and procedures. Ensure alignment with other PTC Quality teams and linkage with the overall Roche Quality and business strategies. Ensure pragmatic, patient-centered problem solving is carried out with a strong sense of purpose and urgency. Contribute to the design and implementation of the necessary Quality standards relevant to Cell & Gene therapy ATMPs within the Roche PQS, in line with applicable international regulations. Foster an environment of continuous quality improvement with a strong focus on process and procedural simplification. Provide leadership to the Quality Systems organization to ensure that teamwork, high morale and innovation are fundamental components of the team. Lead and coach the members of the Quality organization to achieve organizational goals as well as employee personal and professional growth. Develop and maintain an environment of strong collaborations and partnership with internal PTC functions and relevant Roche stakeholders as well as with external partners. Develop annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources. Qualification:
Bachelor's Degree or postgraduate degree in a Life Sciences, Pharmacy, Engineering or related science discipline required. 15
years of experience (or advanced degree
10 years) in the Pharma/Biopharmaceutical industry with experience in aseptic operations, Biologics and ATMPs manufacturing. Experience production gene therapy production and/or analytics is an advantage. 8
years leading teams. Strong knowledge of GxP regulations and how to apply them to clinical and commercial products to guarantee patient safety and ensure the appropriate level of compliance. Agile leader who demonstrates commitment to change, align and help others embracing change. Manages ambiguity through effective communication, removes barriers and overcomes resistance skillfully. Autonomous with ability to manage complex situations successfully as well as to coordinate multiple tasks and manage priorities to deliver on optimum results Demonstrates high integrity and accountability for their area by ensuring team(s) actions and decisions are aligned to business objectives Demonstrates strong collaboration and teamwork skills with a wide assortment of stakeholders from technical/scientific experts to business leaders. Excellent verbal and written communication skills in English, including the ability to present both strategic objectives and tactical actions clearly and concisely May be asked to travel internationally
Salary Range:
$250K -- $500K+
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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