Head of Risk Based Quality Management

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Function: PDQ

Department: RBQM CoE

Location: Global

In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes
 

RBQM Head:

Risk Based Quality Management (RBQM) is a proactive risk management approach that directs focus to the areas of greatest operational risk while maintaining quality and compliance and reducing low impact work. RBQM is a system that reduces the errors that matter to the protection of participant safety, the reliability and interpretability of the study data, and the decisions made based on the study results. RBQM helps study teams to design quality and maintain trial oversight through ongoing and continuous surveillance of information, trends and metrics. By building quality and risk management approaches into the scientific design and operational conduct of clinical trials, risks can be mitigated and issues can be detected early on, or prevented entirely.

The RBQM Head plays a critical role in ensuring the success of embedding  RBQM  at Roche. This senior position is responsible for spearheading the strategic technical & process direction of the RBQM Center of Excellence (CoE) ecosystem; essential for effective RBQM implementation.  In this role it will be crucial to ensure alignment between process and people while ensuring the right skills and talent are in place to support the RBQM ecosystem . The ideal candidate blends strong technical/systems knowledge with strategy leadership.  They have the ability to strategically lead a team in a fast-paced environment where there is often ambiguity. With the right technical strategies, processes and talent in place, the RBQM Head can ensure that RBQM leads to improved risk management, enhanced quality oversight, and more efficient clinical trial and drug development processes.

Key Accountabilities:

Lead and Develop Talent

• Leads a group of senior RBQM specialists within the RBQM CoE.

• Actively develops and champions opportunities for RBQM talent.

• Serves as role model in demonstrating Roche's Leadership Commitments and the Pharma Operating Principles.

• Embraces and role models agile and collective leadership behaviors and a growth mindset.

• Promote and coach continued development of talent through opportunities supporting work products both within and outside of RBQM CoE.

• Advocate for DEI by promoting and practicing inclusive leadership by ensuring all voices are represented, heard and respected.

Strategy Development and Execution

• Drive and influence the RBQM Vision, strategy and execution for the RBQM CoE

• Drive the Pharma Development Quality (PDQ) vision of confidence in the integrity of our data and our processes leading to unrivaled transparency with health authorities, patients and society.

• Maintain a broad system awareness of the organization and industry to ensure a strategic direction in consideration of industry trends, regulatory requirements, stakeholder and partner complexities and technical gaps and opportunities

Innovation and Continuous Improvement

• Champion a culture of innovation and continuous Improvement within the RBQM CoE which will ensure operational efficiency and effectiveness.

• Ensure fit for purpose processes, tools and technology are part of the RBQM ecosystem

• Monitoring and evaluating performance of RBQM process solutions to identify and drive continuous improvement efforts

Stakeholder/Partner Engagement and Alignment

• Engage stakeholder and partner groups across the organization (i.e.PDG, PDD, PDC, PDS, IT, pRED, gRED, MAs) to understand their business drivers and objectives and influence to ensure functional strategies are aligned with RBQM vision and strategy.

• Maintain relationships with key stakeholders and decision makers across various groups within the organization.

Process & Governance

• Ensure fit for purpose processes and governance is in place to support the  RBQM ecosystem.

• Ensure alignment and coordination of RBQM process with other global processes

• Oversee the implementation and integration of RBQM processes within the organization, 

• Ensure appropriate organization training & coaching is established and delivered in RBQM.

• In partnership with stakeholders ensure sustainability and efficiency of RBQM COE operations through fit-for purpose systems, tools and technology.

Who are we looking for?

We are seeking a highly motivated and committed individual who brings the following competencies (not a mandatory requirement that all items below are fulfilled):

• Strong leadership, communication and collaboration skills to manage a cross-functional team working in an ambiguous environment  and liaise with internal and external stakeholders.

• Strong background in clinical research, quality management, and regulatory compliance.

• Strong system awareness across the Roche Organization (i.e. Clinical Science, Data Science, Operations, Safety Science, Regulatory, Quality in addition to other business units (pRED, gRED, MAs)

• Expertise in RBQM processes, including awareness of industry strategy and direction, knowledge and understanding of ICH/GCP requirements.

• Create an inclusive environment by acknowledging all dimensions of diversity and actively practicing Allyship.

• Strong technical expertise in RBQM 

• Effectively drives and influences decision making 

• Excellent project management and agile working skills

• Effective communication and collaboration skills across technical and non-technical stakeholders

• Openness to new ways-of-working, challenging the status quo and seeking new and more effective ways to ensure quality and address issues identified

• Analytical, problem-solving and decision making skills to identify, evaluate, and mitigate risk

• Ability to identify gaps in existing strategies and contribute to development of solutions

• Enterprise thinking and entrepreneurial mindset

Candidates will be a full time, senior core team member within the RBQM CoE, reporting directly to the Global Head of RBQM. This role is headquarter based. 

Qualifications:

Minimum:

• Bachelor's or advanced degree in Life Sciences, , Computer Science, Information Technology or a related field

• 10+ years of experience in a technical role, preferably in the pharmaceutical or clinical trial industry

Desired:

• Previous experience managing global teams and people management 

• Experience with RBQM design and methodology 

• Experience implementing agile project management principles, practices 

• Experience overseeing cross-functional teams PDQ Vision:

Your Application

Please provide your current compelling CV & Cover Letter. The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.

The role will be based at our Welwyn, Basel or Mississauga sites. Please note that we are not able to provide any relocation benefits.

Some travel might be required to support global projects.

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

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.