Head of Global Quality Management & Post Market Surveillance at Roche in Indianapolis, IN
Who We Are Doing now what patients need next. A pioneer in the development of blood glucose monitoring and insulin delivery systems, Roche Diabetes Care (RDC) is committed to helping people with diabetes everywhere in the world think less about their daily diabetes routine, so they can get true relief, day and night. We offer a broad portfolio of solutions for both people with diabetes and their professionals - from blood glucose monitoring to information management to insulin delivery to continuous glucose monitoring. Our aim is to offer innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management. We are strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients. The Opportunity We aim to further shape and advance the way diabetes is treated by leveraging our integrated Personalised Diabetes Management approach (iPDM) - a holistic, patient-centric concept to diabetes management that includes connected devices, services, and digital solutions in an open ecosystem which will contribute to limiting the progression of the disease, and improving outcomes thus eventually promoting healthcare system sustainability. In order to do so, we are continuously refining our internal structures and processes to best serve evolving customer and market demand in a seamless and agile way. This enables us to deliver on our commitment to augment access to the most innovative iPDM solutions tailored to the needs of people with diabetes, their caregivers, and healthcare systems - today and in the future. As Global Head of Quality Management and Post Market Surveillance , you will play a key role in shaping and implementing relevant aspects of the iPDM Strategy and thereby contribute to the overall Diabetes Care Vision at Roche. Job Facts Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continuous improvement efforts. Quality is every patient's right and every employee's responsibility. As Global Head of Quality Management and Post Market Surveillance, you will be accountable to ensure the leadership and strategic direction for our right to operate across the globe. You will lead the new established area of Quality Management, Systems & Post Market Surveillance. Your key
Responsibilities:
Within this role, your responsibilities will fall into these main areas:
Strategy In this role you provide strategic direction for different quality functions and set policy and strategy for your own department. You are responsible for strategy development and implementation of the training process and system and for GxP training across Diabetes Care You partner with the internal/external manufacturing heads on strategic business direction and decisions. You develop and communicate organizational strategies, which ensure the compliance of the sites, continuous improvements and achievement of long term goals. You will build effective relationships with all interfaces to ensure compliance to applicable regulatory & quality management requirements, with a special focus on proactive communication and enabling strategic quality related solutions. You provide strategic decision making, leadership and planning including the efficient and effective use of resources. You are an inspirational leader who can create a compelling vision where diverse disciplines can align; develop to pursue the organizations North Star. Implementation You act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions by consistent business behavior that complies with applicable laws, industry codes and Roche's Code of Conduct. You ensure that Quality Standards (linked to key regulatory requirements, e.g. FDA and EU (IVDR/MDR), and to standards, e.g. ISO 13485) are implemented and adhered to. You are accountable to ensure Health Authority regulations, Notified Body requirements, Company standards and expectations are translated into lean processes and templates, digested and understood. You define QMS (Quality Management System) requirements. You implement globally business process management systems (processes, tools, data) to transform business, digitalize and manage different aspects of business processes and product lifecycle You carry out the quality planning to drive continuous improvements and changes of the quality systems to ensure ongoing effectiveness and efficiency and increase speed to market for our products. You ensure the Quality Policy is understood, implemented and maintained in the Diabetes Care organization You ensure appropriate divisional oversight over all other local and regional quality systems You make final decisions together with the Safety Board Leader and Medical Lead on escalated safety board topics, escalated correction and removal decisions, divisional standards associated with quality and global quality and regulatory policy activities. You plan, manage and conduct audits (internal, external and supplier) and manage audit results and responses to authorities (incl. collaborate with auditees to identify and implement sustainable corrective actions and develop and maintain process for shared learnings from audits to drive continuous improvements across the division and our suppliers) This position has final approval together with the Global Head of OneMedical on responses to regulatory authorities on significant matters including, for example, 483 responses, Warning Letters, and any enforcement actions. You collaborate closely with the DIA and Pharma Division to ensure a OneRoche approach to compliance, specifically in the area of training. You ensure that appropriate Post Market Surveillance processes are established for all Diabetes Care products You are responsible for the evaluation and investigation of complaints You guarantee that incidents and recalls (e.g. field corrections, removals,) are globally handled according to national law(s) for products where Roche Diabetes Care acts as legal manufacturer You are responsible for providing Global Corrective and Preventive Action (CAPA) process leadership You are responsible for Quality Management, Supplier Quality Management, and Quality Assurance (US, DE) for all Diabetes Care products. You communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management and actively support to solve them Entrepreneurial You are accountable and responsible for cost control & budget for the entire department. You will be an active member of the Global Operations & Quality Leadership team. You represent Roche Diabetes Care in selected trade associations or other bodies. Leadership You act as a role-model for Agile Leadership behaviors, and be a strong advocate of our culture, mindset & behaviors as defined in We@RocheDiabetesCare. You lead in a manner that is consistent with the Roche Values and leadership capabilities within the Creative Leadership and the VACC (Visionary, Architect, Catalyst, Coach) framework and more broadly if required, to ensure individuals and teams are developing and growing in line with their passion and the needs of the Organization. You lead and manage all aspects of people processes - organization, staffing, talent management, development and performance management to meet strategic and operational objectives. You create an environment of strong team spirit, timely & effective communications, sense of urgency, high motivation and inspire the team to achieve goals in the immediate and longer term. You establish strategic goals and objectives. You direct staff in setting operational objectives and business goals for their respective areas of responsibility. You are an active and visible change agent, promoting flexible and open mindsets to new opportunities. You proactively promote positive Safety Culture principles. As a leader, you drive network activities and alignment, cross-functional planning, and decision making. You establish agile ways of working where appropriate You support a Lean culture within Global Operations & Quality and Roche Diabetes Care. Who You Are We are looking for a passionate and decisive business leader. You demonstrate energy, passion, courage, vision and the drive to be part of an organization at the forefront of the industry, delivering benefits for patients, our people, and our business. Moreover, you bring:
Professional and Technical Requirements You have a Bachelor's / Master degree in Life Science, Pharmacy or related subject. Advanced degree is considered an advantage. You have 8
years of demonstrated leadership experience or equivalent experience in the Medical Device/Pharma/Biopharmaceutical industry with at least 5 years working in Quality, Compliance, Regulatory (preferred or equivalent experience). You have demonstrated experience and knowledge of QMS and processes. You have excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards. You are experienced with new ways of working (e.g. Agile) and process management tools (e.g. Lean Management). Knowledge and experience in strategic planning, business planning, finance, and operations management desired Other skills requirements You are energetic to drive change and find solutions quickly and effectively, taking into account the impact to other teams cross-functionally. You demonstrate the ability to build networks and you inspire agile working. You have a strong track record in prioritizing and simultaneously managing multiple projects (activities) in a fast paced environment for timely completion of projects. You have solid professional and interpersonal skills to effectively operate globally with diverse cultural groups. You create a working environment and team culture for staff where innovation is encouraged and enabled, using agile methods. You bring the ability to interact at senior level and manage key stakeholders. You are able to interact with peer groups and respond to questions in a manner consistent with professional etiquette. You have very strong English communication skills (oral and written). You are willing to travel frequently. Key leadership skills required You assess team structures and potentials, and develop individual and team development plans together with the team members. You have creative personnel leadership experience in a fast-paced and rapidly changing business environment. You are accountable for fostering a culture where every individual, across the organization, is able to bring his or her whole self & passion to work. You will be expected to demonstrate the We@RocheDiabetesCare dimensions and help evolve the functions culture beliefs and bring We@RocheDiabetesCare to life, as part of the iPDM Strategy Implementation.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Within this role, your responsibilities will fall into these main areas:
Strategy In this role you provide strategic direction for different quality functions and set policy and strategy for your own department. You are responsible for strategy development and implementation of the training process and system and for GxP training across Diabetes Care You partner with the internal/external manufacturing heads on strategic business direction and decisions. You develop and communicate organizational strategies, which ensure the compliance of the sites, continuous improvements and achievement of long term goals. You will build effective relationships with all interfaces to ensure compliance to applicable regulatory & quality management requirements, with a special focus on proactive communication and enabling strategic quality related solutions. You provide strategic decision making, leadership and planning including the efficient and effective use of resources. You are an inspirational leader who can create a compelling vision where diverse disciplines can align; develop to pursue the organizations North Star. Implementation You act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions by consistent business behavior that complies with applicable laws, industry codes and Roche's Code of Conduct. You ensure that Quality Standards (linked to key regulatory requirements, e.g. FDA and EU (IVDR/MDR), and to standards, e.g. ISO 13485) are implemented and adhered to. You are accountable to ensure Health Authority regulations, Notified Body requirements, Company standards and expectations are translated into lean processes and templates, digested and understood. You define QMS (Quality Management System) requirements. You implement globally business process management systems (processes, tools, data) to transform business, digitalize and manage different aspects of business processes and product lifecycle You carry out the quality planning to drive continuous improvements and changes of the quality systems to ensure ongoing effectiveness and efficiency and increase speed to market for our products. You ensure the Quality Policy is understood, implemented and maintained in the Diabetes Care organization You ensure appropriate divisional oversight over all other local and regional quality systems You make final decisions together with the Safety Board Leader and Medical Lead on escalated safety board topics, escalated correction and removal decisions, divisional standards associated with quality and global quality and regulatory policy activities. You plan, manage and conduct audits (internal, external and supplier) and manage audit results and responses to authorities (incl. collaborate with auditees to identify and implement sustainable corrective actions and develop and maintain process for shared learnings from audits to drive continuous improvements across the division and our suppliers) This position has final approval together with the Global Head of OneMedical on responses to regulatory authorities on significant matters including, for example, 483 responses, Warning Letters, and any enforcement actions. You collaborate closely with the DIA and Pharma Division to ensure a OneRoche approach to compliance, specifically in the area of training. You ensure that appropriate Post Market Surveillance processes are established for all Diabetes Care products You are responsible for the evaluation and investigation of complaints You guarantee that incidents and recalls (e.g. field corrections, removals,) are globally handled according to national law(s) for products where Roche Diabetes Care acts as legal manufacturer You are responsible for providing Global Corrective and Preventive Action (CAPA) process leadership You are responsible for Quality Management, Supplier Quality Management, and Quality Assurance (US, DE) for all Diabetes Care products. You communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management and actively support to solve them Entrepreneurial You are accountable and responsible for cost control & budget for the entire department. You will be an active member of the Global Operations & Quality Leadership team. You represent Roche Diabetes Care in selected trade associations or other bodies. Leadership You act as a role-model for Agile Leadership behaviors, and be a strong advocate of our culture, mindset & behaviors as defined in We@RocheDiabetesCare. You lead in a manner that is consistent with the Roche Values and leadership capabilities within the Creative Leadership and the VACC (Visionary, Architect, Catalyst, Coach) framework and more broadly if required, to ensure individuals and teams are developing and growing in line with their passion and the needs of the Organization. You lead and manage all aspects of people processes - organization, staffing, talent management, development and performance management to meet strategic and operational objectives. You create an environment of strong team spirit, timely & effective communications, sense of urgency, high motivation and inspire the team to achieve goals in the immediate and longer term. You establish strategic goals and objectives. You direct staff in setting operational objectives and business goals for their respective areas of responsibility. You are an active and visible change agent, promoting flexible and open mindsets to new opportunities. You proactively promote positive Safety Culture principles. As a leader, you drive network activities and alignment, cross-functional planning, and decision making. You establish agile ways of working where appropriate You support a Lean culture within Global Operations & Quality and Roche Diabetes Care. Who You Are We are looking for a passionate and decisive business leader. You demonstrate energy, passion, courage, vision and the drive to be part of an organization at the forefront of the industry, delivering benefits for patients, our people, and our business. Moreover, you bring:
Professional and Technical Requirements You have a Bachelor's / Master degree in Life Science, Pharmacy or related subject. Advanced degree is considered an advantage. You have 8
years of demonstrated leadership experience or equivalent experience in the Medical Device/Pharma/Biopharmaceutical industry with at least 5 years working in Quality, Compliance, Regulatory (preferred or equivalent experience). You have demonstrated experience and knowledge of QMS and processes. You have excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards. You are experienced with new ways of working (e.g. Agile) and process management tools (e.g. Lean Management). Knowledge and experience in strategic planning, business planning, finance, and operations management desired Other skills requirements You are energetic to drive change and find solutions quickly and effectively, taking into account the impact to other teams cross-functionally. You demonstrate the ability to build networks and you inspire agile working. You have a strong track record in prioritizing and simultaneously managing multiple projects (activities) in a fast paced environment for timely completion of projects. You have solid professional and interpersonal skills to effectively operate globally with diverse cultural groups. You create a working environment and team culture for staff where innovation is encouraged and enabled, using agile methods. You bring the ability to interact at senior level and manage key stakeholders. You are able to interact with peer groups and respond to questions in a manner consistent with professional etiquette. You have very strong English communication skills (oral and written). You are willing to travel frequently. Key leadership skills required You assess team structures and potentials, and develop individual and team development plans together with the team members. You have creative personnel leadership experience in a fast-paced and rapidly changing business environment. You are accountable for fostering a culture where every individual, across the organization, is able to bring his or her whole self & passion to work. You will be expected to demonstrate the We@RocheDiabetesCare dimensions and help evolve the functions culture beliefs and bring We@RocheDiabetesCare to life, as part of the iPDM Strategy Implementation.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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