Head of Quality Systems, Management and Fundamentals at Roche in South San Francisco, CA
PTQ has a critical role in delivering safe and efficacious medicines to patients. To ensure we meet our commitment to the Roche Pharma Vision, we are evolving to become a more flexible, efficient, and collaborative organization. We are doing this by creating and developing a new organizational framework, made up of complementary and overlapping areas. This framework is specifically designed to encourage and facilitate end-to-end thinking, flexibility and collaboration -- with the ultimate goal of helping us deliver quality medicines as efficiently as possible. We are now seeking an accompanying 'Enabling Team' that can support the teams and people within the framework, and facilitate the accomplishment of their business objectives. Reporting to the Head of PTQ, members of the Enabling Team will play a crucial role in supporting PTQ pursue its vision; 'All Value. Zero Waste. For Patients', and your energy and drive will inspire colleagues to discover new ways of 'radically simplifying' and 'pioneering for excellence'. The Enabling Team must collectively shape and execute Global Quality and Compliance strategies in alignment with the PT strategy, and ensure PTQ delivers its commitment to the Pharma Vision. Job Facts This position is accountable for the fundamental Quality System and Quality Management aspects of quality and compliance activities throughout PT. The successful candidate will be accountable for:
Establishing PT's fit-for-purpose Pharmaceutical Quality Management System which describes how we comply with global Health Authority and ISO requirements and accompanying Quality IT systems which enable compliance. Ensuring and maintaining the health of the Quality Management system and accompanying Quality IT systems Auditing and monitoring process performance, quality system health and product quality which drives actions to improve and sustain global quality and compliance Implementing robust risk management to realize proactive mitigation of risks before they become issues Ensuring comprehensive knowledge management that enables a learning organization Lead an empowered area with a wide range of expertise (coming from multidisciplinary functions) to ensure Right to Operate by implementing a Quality and an End-to-End mindset. Orchestrate priorities of our changing portfolio towards resilient supply and launch excellence in collaborations with MUs and Development functions. Actively partner with respective stakeholder/s to drive One Quality Voice and ensure strategic alignment (MUs, Development Functions) Drive convergence between different Site Q functions with a network mindset and continuous improvement for key Quality and GMP operational aspects. Own / responsible for the compliance and adherence to HA standards and expectations. Operates in compliance with international GMP Standards. Budgeting and Financial Performance:
Accountable for overall budget and financial performance of assigned area and jointly responsible for performance of PTQ as a whole. Organization and Resources:
Directly responsible for staffing, talent management, budgeting and resource allocation Ensure area operations meet global standards/principles with regards to organization, personnel, qualification, training, procedures, processes, performance, productivity Evaluate Quality performance (KPIs and Quality reporting) in the assigned area and for the entire PTQ, proactively involved to enable progress on projects/initiatives as well as issues/Quality related escalations that might arise. Who you are You are a leader that can nurture an environment where people feel included, feel safe to learn through experimentation, feel able to be themselves and have the opportunity to do their best work. You'll already be noted for your ability to inspire colleagues, keeping them focused on a clear vision, and a talent for coaching teams to innovate and look for ways to simplify, and pioneer technical excellence. You have a well-established network across the Pharma Industry and can readily build one quickly within Roche/Genentech. This role requires you to collaborate, influence and build trust across levels within an international and cross-functional environment. You bring a significant amount of business acumen, a solution-oriented mindset, and an ability to stay focused in ambiguous and pressured situations. Comprehensive technical knowledge and experience in quality or associated manufacturing areas is required as are outstanding communication skills. Bachelor's in Life Sciences, Business or Engineering, Master in Business or Life Science preferred Minimum 15 years industry experience in biotech or Pharma industry with strong quality and compliance background., Experience in site and global roles with a demonstrated ability to lead large, complex and collaborative global organizations;
Salary Range:
$250K -- $500K+
Minimum Qualification
Quality Management, Operations ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Establishing PT's fit-for-purpose Pharmaceutical Quality Management System which describes how we comply with global Health Authority and ISO requirements and accompanying Quality IT systems which enable compliance. Ensuring and maintaining the health of the Quality Management system and accompanying Quality IT systems Auditing and monitoring process performance, quality system health and product quality which drives actions to improve and sustain global quality and compliance Implementing robust risk management to realize proactive mitigation of risks before they become issues Ensuring comprehensive knowledge management that enables a learning organization Lead an empowered area with a wide range of expertise (coming from multidisciplinary functions) to ensure Right to Operate by implementing a Quality and an End-to-End mindset. Orchestrate priorities of our changing portfolio towards resilient supply and launch excellence in collaborations with MUs and Development functions. Actively partner with respective stakeholder/s to drive One Quality Voice and ensure strategic alignment (MUs, Development Functions) Drive convergence between different Site Q functions with a network mindset and continuous improvement for key Quality and GMP operational aspects. Own / responsible for the compliance and adherence to HA standards and expectations. Operates in compliance with international GMP Standards. Budgeting and Financial Performance:
Accountable for overall budget and financial performance of assigned area and jointly responsible for performance of PTQ as a whole. Organization and Resources:
Directly responsible for staffing, talent management, budgeting and resource allocation Ensure area operations meet global standards/principles with regards to organization, personnel, qualification, training, procedures, processes, performance, productivity Evaluate Quality performance (KPIs and Quality reporting) in the assigned area and for the entire PTQ, proactively involved to enable progress on projects/initiatives as well as issues/Quality related escalations that might arise. Who you are You are a leader that can nurture an environment where people feel included, feel safe to learn through experimentation, feel able to be themselves and have the opportunity to do their best work. You'll already be noted for your ability to inspire colleagues, keeping them focused on a clear vision, and a talent for coaching teams to innovate and look for ways to simplify, and pioneer technical excellence. You have a well-established network across the Pharma Industry and can readily build one quickly within Roche/Genentech. This role requires you to collaborate, influence and build trust across levels within an international and cross-functional environment. You bring a significant amount of business acumen, a solution-oriented mindset, and an ability to stay focused in ambiguous and pressured situations. Comprehensive technical knowledge and experience in quality or associated manufacturing areas is required as are outstanding communication skills. Bachelor's in Life Sciences, Business or Engineering, Master in Business or Life Science preferred Minimum 15 years industry experience in biotech or Pharma industry with strong quality and compliance background., Experience in site and global roles with a demonstrated ability to lead large, complex and collaborative global organizations;
Salary Range:
$250K -- $500K+
Minimum Qualification
Quality Management, Operations ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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