Associate Group Director, PV Quality Management

The PositionAssociate Group Director, PV Quality ManagementWho We AreAt Roche, we are passionate about transforming patients lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.Purpose of the Associate Group DirectorThe Associate Group Director within this sub-function is a highly experienced safety and Quality Management System (QMS) leader. They are responsible for leading a team to support the Senior Group Director PVQM in developing, implementing, maintaining and improving the Quality Management System. In the context of the PV System and the PDS business function as an important component of how the quality of PDS business delivery, and the effectiveness of the Roche-wide PV system, can be overseen and managed.The job holder will work in closely with the Senior Group Director, PVQM and his/her peers to deliver the following critical components of QMS development and support at the PV system and/or PDS functional levels:The jobholder works as part of the PVQM leadership team to support the design and implementation of the functional strategy for quality or the implementation of the QMS across the PDS function and the wider PV system. Including taking on personal responsibility for shaping defined areas of this strategy; leading relevant business changes that are involved and managing relevant stakeholders collaboration, including at senior levels.The jobholder ensures the team provides effective support to the design, delivery and continuous improvement of operational processes for the PDS function and/or its key stakeholders (e.g. quality by design; effective CAPA design; process improvements; design, implementation & oversight of PV process KPIs and activities to support measures of business process efficiency, productivity, and/or scientific quality).Responsible for ensuring relevant approaches to quality management are deployed by the team in line with good practice (e.g. process design, effective audit & inspection management, deviation & finding management, key performance indicators, analyses and trending approaches).Act as a subject matter expert with regard to regulatory requirements relating to PV quality management and contributes to relevant Roche policies, practices and PV-related processes in these areas (e.g. PSMF content; PV system wide metrics design).Responsible for influencing PV delivery teams within and beyond PDS, regarding ongoing quality data generation. Working with relevant governance teams and senior leaders (e.g. EU QPPV, GVP/GCP Councils, PDQ, etc) to ensure that information and knowledge generated around quality and performance measurement can support effective decisions.The job holder is responsible for the effective line-leadership of their assigned team, in a manner that is consistent with the Roche Values and leadership capabilities.May be required to deputise for the Senior Group Director PVQM when required.Primary Responsibilities and AccountabilitiesAccountable for providing effective line leadership for the global team; in line with the Roche Values and Roche Leadership commitments.Responsible for coordinating a team to deliver the ongoing development, implementation, improvement, and delivery of a variety of PV system-wide, and PDS-specific QMS elements.Actively promotes a collaborative culture, innovative thinking, and quality and agility mind-set in the global team; to support the remit and growth of the collective group.Responsible for the provision of relevant subject matter expertise in relation to PDS/PD-wide processes and related systems, interfaces and enabling infrastructure, in areas relevant to the enterprise wide Roche PV system QMS.Collaboration and interface with internal policy governance bodies/stakeholders (e.g. EU QPPV, GVP Council, etc.) in the development of oversight mechanisms and continuous improvement solutions for the PV system/QMS.Responsible for ensuring effective capacity management across the team, in conjunction with the Global Head, so that future resource priorities are anticipated and adequately supported.Responsible for recruitment, performance, retention and talent management of the assigned global team. Ensuring the team are coached, trained and developed in order to maximise their personal potential, wellbeing, and contributions to the business.Responsible for providing strategic direction to the assigned team and credible leadership that promotes their development, motivation and ongoing engagement. Helping the team to define priorities and goals in alignment with wider priorities.Responsible for sustaining effective partnerships with key stakeholders across PDS (e.g. QPPV) and across PD (e.g. PDQ) and external to PD to ensure effective delivery of PV System QMS design and operation including effective partnering to drive improvements/enhancements to the PDQ owned QMS frameworkResponsible for ensuring the assigned global team can anticipate, influence external regulations and/or Roche policies, practices and processes relating to PV compliance and business performance measurement. Also responsible for maintaining personal knowledge and awareness in these areas in order to support the business and participate effectively in PV inspection and audit activities.Demonstrates the ability to adopt a range of influencing styles and communication techniques to role-model collaborative working across the PV System and ensure the team is able to negotiate the adoption of effective quality management standards.Accountable for leading or supporting PDS or PD wide improvement projects, designed to address business issues relating to the quality management system or relevant implementation of new regulations/legislationThe role specifically may include all or some of the following accountabilities to be delivered between the jobholder and his/her peer(s):Monitoring Compliance of the PV System and its QMSMay act as, or line manage the individual who acts as, the GPO for the Compliance Monitoring process ensuring:a robust and comprehensive CM strategy is in place and is maintained via metric road map to deliver continuous improvement to the system and processdesign and implementation of relevant metrics for all PVS process metrics in collaboration with the GPOs and the EU QPPV/GVP Council;effective business ownership of the PDS Compliance Monitoring tool including maintaining a roadmap for continuous improvement of the system & metrics strategyOversight of the end to end PV System compliance monitoring process to ensure effective delivery of monthly compliance reports and materials for quarterly compliance presentation to GVPC for requisite governance oversight, managing actions from governance to ensure actions are taken on any issues or trends identifiedEffective liaison with other PD wide stakeholders to ensure a coordinated metrics strategy is implemented for the PV system between global and across the affiliatesDeliver timely and accurate production of Annex F for the PSMFClinical and Safety Findings Management (CSFM)Manage individuals acting as Global Process Quality Responsible (GPQR) providing support and oversight to ensure delivery of this key accountability for PDS owned processes to deliver effective management and solution to all finding types.Provide input into complex finding management with regards to root cause analysis and the design of effective and pragmatic solutions to address findings driving compliance and process improvement.Provide functional level oversight of performance of the CSFM process within PDS, identifying strategies & solutions for improvement, driving compliance to the processPDS Procedural Document Framework ManagementOversight of the strategy and process for management of PDS owned functional business process documents working closely with GPOs, delivering functions and PDQ to enhance robustness of the overall QMSManage team in the delivery of high quality functional owned business process documents including supporting/leading process design ensuring quality is embedded; ensure alignment of process documents across PDS functional groupsAccountable for the PV HIVE resource tool utilized by PDS, LSRs and the wider business community for understanding of the end to end PV system and the complete suite of process tools and documents in place.Partner closely with PDQ on procedural document framework strategy to ensure overall needs for GVP are met and maintainedDeliver timely and accurate production of Annex E of the PSMFAudit and Inspection ManagementManage resources for provision of inspection and audit support accountabilities to deliver effective document management strategy pre and during audits/inspections.Ensure delivery of timely and high quality PDS accountable document requests for; PV inspections, PDS owned process audits and Business Partner PV audits; working closely with PDQ, IQM and PDS GO/expert network.May act as the formal PDS Functional Representative for key PV inspections according to the PV Inspection Strategy or Deputize for the Global Head in this role.Act as SME for PVS QMS areas of expertise during inspections and participate as an interviewee as required.Professional and Technical RequirementsA degree in a relevant discipline with strong experience in areas relevant to pharmacovigilance, clinical quality management, business performance management, business analysis, and/or process management.A postgraduate qualification in an area relevant to PV, quality management and/or business performance management/analysis would be advantageous.An excellent understanding of quality management and associated approaches is essential. Significant business experience in areas relevant to PV, clinical quality management, business performance management, or related disciplines is required.Excellent leadership skills, with the proven ability to lead global line- or matrix- teams in accordance with the Roche leadership commitments and values with good experience in leadership positions, preferably with some direct line management experience.Highly developed influencing and negotiating skills, with proven ability to influence without authority in a complex matrix organisation are important.Advanced analytical thinking skills, ability to rapidly assimilate complex information to inform decisions, and/or make effective business proposals in situations of ambiguity. Sets high standards and has keen attention to detail. Able to operate objectively and independently, deciding when to communicate or escalate issues where appropriate. Able to remain articulate and convey complex information credibly under pressure.Experience of leading and/or supporting PV inspections and auditsThe ability to understand key pharmacovigilance or GCP safety legislation and regulatory requirements; assess any implications relevant to quality management, PV or GCP safety compliance; and to then propose plans/options for the successful implementation of QMS-related changes in the business, are essential.Proficiency with relevant data analysis and process or information management/visualisation systems/tools would be an advantage.The ability to apply analytical thinking to the design, implementation, review and/or delivery of complex, cross-functional processes, measures, metrics, key performance indicators and/or management information system design.Working knowledge of the key activities involved in clinical research and development in the pharmaceutical industry.Excellent oral and written communication skills and ability.Travel Requirements:Occasional International business travel is likely to be required.If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. Every role at Roche plays a part in making a difference to patients lives. If you want to work in a passionate team, make your mark and improve lives, apply now.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions. Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche.The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.

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