PV Quality Director

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The Position

Are you passionate about quality and ready to lead and inspire in a dynamic role at Roche?

As a PV Quality Director, you will play an important role in our Pharmacovigilance Quality Management (PVQM) function. Your mission will support delivery of the highest standards of patient safety and regulatory compliance, with a focus on deviation management within the Product Development Safety Risk Management (PDS) function. Join us to make a significant impact by leading the investigation, planning and implementation of measures to address process deficiencies and non-compliances for specific process areas, as well as supporting PV/GCP Safety audits and fostering a culture of continuous improvement.

The Position

As a PV Quality Director in the defined role of Global Quality Process Responsible, you will be accountable for:

• Determining if a finding/deviation is valid and assigning criticality

• Leading Root Cause Analysis activities

• Drafting corrective action and preventive action (CAPA) plans and effectiveness measures

• Overseeing CAPA plan implementation

• Reviewing evidence and performing effectiveness checks

• Identifying and escalating issues if timelines may be at risk

• Performing trend analysis on deviation/finding data, with input from subject matter experts and in collaboration with the Global Process Owner (GPO)

• Supporting activities relating to the conduct of GVP/GCP Safety audits and inspections

• Leading other PV system related QMS activities, as required

Who you are

• Quality experience: Experience in a pharmacovigilance or a clinical safety related area including quality-related activities; strong experience in design and management of CAPA is essential, together with knowledge of key GVP regulatory requirements, in particular those relating to quality and quality management systems.

• Collaborative and results driven: You enjoy building strong relationships with your global stakeholders, and are able to collaborate and influence effectively to deliver quality and results in a matrix environment

• Analytical and process-focussed: you are able to process and manipulate data, analyse and report information to stakeholders effectively, in order to facilitate decisions and knowledge sharing

• Passionate and self-motivated: You are independent and well organised, with good attention to detail, and are able to work simultaneously on complex and/or multiple projects/activities with excellent time management skills

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.