Quality Solutions Head for QMS Development
Vor 4 Tagen
The Position
Together, we'll advance along the whole patient journey with the aspiration to prevent, stop and cure diseases.
The PD Quality Solutions (PDQS) Heads are accountable for the development and implementation of an enterprise-wide Pharma R&D Quality Management System (QMS) excellence strategy covering end-to-end regulated processes conducted by Pharma global functions, REDs, affiliates, service providers, and development partners. The QMS excellence strategy delivers process integrity via compliant, effective, efficient end-to-end processes that increase health authority (HA) confidence in our QMS via adherence to GCP, GVP, medical device and other applicable requirements, adding value for Roche and our patients.
The QMS excellence strategy reflects an efficient, connected, pipeline-driven OneRoche approach for end-to-end processes by anchoring to and adhering to industry standards of Critical to Quality (CtQ) factors.
Through strategically partnering with business partners such as Global Process Owners (GPOs), Roche Pharma R&D leaders and experts in the affiliates, Pharma Technical, IT and Roche's Diagnostics division, the PDQS Heads continuously attunes the QMS excellence strategy to deliver value and impact, ensuring organizational and systems alignment and consistency across R&D functions, affiliates, service providers and development partners in its implementation.
The PDQS Heads provides strategic direction and dynamic leadership in a global enterprise environment and is recognized in Roche as an authority and thought leader on the end-to-end processes or quality infrastructure of their domain.
The PDQS Heads lead teams of direct reports and will focus in one of the following two areas:
1. Accountable for the delivery of the QMS excellence strategy on processes in scope of their assigned domain for the conduct of clinical research, integrated healthcare solutions development, post-marketing and patient safety activities that deliver the Roche Pharma portfolio.
2. Accountable for the strategies and mechanisms that deliver and operationalize critical QMS Tools standards and tools that improve efficiency and maximize PDQS' and the business's ability to focus on value-add activities and accelerate delivery of quality solutions.
Your opportunity
For this role, this PDQS Head is responsible for #2 of the focus areas. Short to mid-term deliverables include:
- End-to-End change control of the QMS
- Automated process management to enable optimization of global process landscape
- Affiliate QMS operations leadership
- End-to-End collaboration model between PD and PT QMSs
Further you are accountable for
- Domain Strategy: you optimise QMS delivery through improvement and risk management and drive strategic process changes and align resource priorities.
- Leadership: you manage teams through ambiguity and align with priorities as well as develop talent and ensure proactive communication.
- Stakeholder Management: you influence and implement QMS solutions through a global network.
- Quality Strategies: you contribute to PDQ, PD, and Pharma goals as well as promote innovation and quality culture.
Who you are
You have a Master's or Bachelor's in a scientific or quality field, or equivalent and bring the following attributes:
- Growth mindset, customer-focused/-entricity
- Strong (English) communication skills in a diverse environment
- Expert in international regulations (GCP/GVP/Device).
- Effective leader and influencer and a track record of this in multicultural organizations
- Proven problem solver with effective decision-making skills
- Inspiring and positive leader to engage with various audiences
Application deadline: 9 March 2025
Please note that we are planning to invite successful candidates to video tape their answers to a handful of questions about a week after the application deadline.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
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