Senior Quality Lead
We are looking for Senior Quality Leads to join our Quality Assurance Programs team!
In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivalled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules, Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes.
We are looking for experienced Senior Quality Leads to join our Quality Assurance Programs team who bring a diversity of thinking and technical experience (GCP, Data Analytics, PHC, Medical Devices, Computerized Systems, Digital Solutions). We want individuals with a growth mindset, who are able to apply their critical, strategic and flexible thinking, and who have the ability to negotiate with and influence key stakeholders with self assurance.
For the positions we are hiring the ideal candidate would be an experienced Quality Professional with:
- Expertise in GCP with the ability to design and execute program level quality assurance strategies working in collaboration with development and study teams. Expertise in Medical Devices (especially Software as a Medical Device), and/or the use of Data Analytics or/and knowledge of Computerized Systems is desirable.
- Expertise in Medical Devices (preference is Software as a Medical Device) with the ability to design and implement Quality Assurance strategies working in collaboration with business stakeholders and product teams.. Desired certifications or qualifications include: ISO 13485 Lead Auditor, EU Medical Device Regulation Auditing, and/or Medical Device Single Audit Program (MDSAP) auditing
The Quality Assurance Programs team is responsible for the design and delivery of Quality Assurance strategies, evidence and actionable data for our molecules, products (drug and/or medical devices), processes, affiliates, service providers and 3rd parties.
(We are a team of 70+ Quality Leads working across five global sites)
A day in the life:
- Design and Implementation of Quality Assurance strategies across molecule/ product (drug and/or medical devices)/process/affiliate levels, defining the activities, partnering and engaging with business stakeholders, using data analytics and insights to target the activities that need to be conducted to provide evidence of effective implementation
- Delivery of activities to assess Quality Assurance status through execution of Quality activities, including preparation, conduct, presentation and timely reporting of outcomes of audits, and evaluation of actions taken looking for areas of opportunity for process improvement beyond the individual findings
- Summarise the quality position and conclusions for entities using the quality evidence generated into the Quality Briefing Document (QBD), with the intent of proactively providing a meaningful and relevant summary of confidence in data collected and processes followed in order to influence and effect change and positive outcomes.
- Present QBD conclusions, observations and associated compliance risks to business stakeholders and Pharma representatives and ensure appropriate action plans have been developed and determine acceptability of evidence of compliance
- Lead discussions to discuss unresolved issues with Senior Management; manage ‘for cause’, critical, and/or complex quality issues and escalate significant issues to PDQ management
- Demonstration of implementation of Quality Assurance strategy to Health Authorities by leading or supporting inspection preparation and management of Health Authority inspections through the provision of inspection training to staff, prepare, review and provide relevant inspection materials on request and presentation of Quality strategies and QBD conclusions and associated documentation during Inspections
Contribute to the development and execution of PDQ goals and initiativesby: participating in or leading departmental or cross-functional compliance projects and initiatives as assigned; leading the development and/or revision of PDQ processes and procedures including SOPs, Work Instructions, and risk assessment tools; Provide education and/or training to business stakeholders as required and acting as trainer and mentor for junior staff providing meaningful feedback on a person’s performance in close collaboration with their line manager
We are looking forward to your application including a 100 word personal statement describing "How my purpose meets Roche/ this role's purpose".
If you are interested in the Senior Quality Lead roles based in the US, in San Francisco or the UK, Welwyn Garden City (both could be office or regionally based) apply now.