Global Head of Device Quality - MDCP

Job description

The Position

Job Summary

Reporting to the Head of Pharma Technical Operations Quality (PTQ), and a member of the PTQ Enabling Team, the Global Head of Device Quality, will play a crucial role in supporting PTQ to pursue its vision; 'All Value. Zero Waste. For Patients', and your energy and drive will inspire colleagues to discover new ways of 'radically simplifying' and 'pioneering for excellence'. As part of PTQ Enabling Team, you will collectively, with peers on the Enabling Team, shape and execute Global Quality and Compliance strategies in alignment with the Pharma Technical Operations strategy, and ensure PTQ delivers its commitment to the Pharma Vision.

You will hold a global end-to-end responsibility for Device Quality - overseeing the End-to-End quality compliance of the Device Development and Lifecycle Process in accordance with relevant Design Controls ( ISO 13485, 21CFR820.30) for Medical Devices and Combination Products. You collectively — along with the other members of the Enabling Team; Head of PTQ and the Transformation & Strategy Lead — will be accountable for Quality and Compliance for Pharma Global Technical Operations (PT).

You are accountable for quality and compliance for all device manufacturing and packaging performed by internal parties, third parties and suppliers; End-to-End Supply Chain, distribution & partner management used by Global Pharma Technical Operations.
 

You are accountable for device regulation knowledge and ensuring quality design for excellence >> timely internal and external quality processes for medical devices and combination products that result in (a) compliance with regulations, and (b) ensure safe and reliable products for our patients. This role is also accountable for the quality oversight of all Drug Product Packaging Development and quality oversight of  device packaging suppliers.

The work of the Device Quality team includes device related product quality (device robustness), quality engineering for device lifecycle, quality oversight, quality agreement, inspection readiness and positive outcome, launch readiness, and operational product quality management including design and development, clinical trial support, design transfer, manufacturing and packaging, and product care including device complaint handling related to device and associated suppliers.

You will partner with functions within Quality and act as Quality Lead and partner with the broader Device community (development and industrialization)

This role is the 

• Management Representative responsible per ISO13485, 5.5.2 and 21CFR820.20(b)(3) for Roche Pharma.

• Person Responsible for Regulatory Compliance (PRRC) for physical medical devices of F.Hoffmann-La Roche Ltd (according Art 15 of the regulation (EU) MDR 2017/745 of the European Parliament and of the council of 5.April 2017 on Medical Devices).

Key responsibilities include:

• Lead an organization of Device Quality Experts to ensure “Right to Operate” by implementing a Quality and an End-to-End mindset.

  • Operational responsibility for: End to End Device activities including Design/Development inclusive of Quality Engineering, Tech Transfer, Clinical Manufacturing, Commercial Manufacturing, Product Discontinuation, Legal Manufacturer accountabilities, Quality Support, Supplier Source & Select; Implement, Manage, Decommission and Distribution

• Hold accountability for Device Quality team members’ ability to deliver.

• Orchestrate priorities of our changing portfolio in collaborations with Device Community.

• Actively partner with respective stakeholder/s to drive One Quality Voice and ensure strategic alignment (Device Community)

• Own / responsible for the compliance and adherence to HA standards and expectations. Operates in compliance with international regulations and ISO/CFR Standards.

• Organization and Resources: Directly responsible for staffing, talent management, and resource allocation

• Ensure the Device Quality  team members have the required capabilities to execute current and future work packages, deliver the team’s objectives and seek ways of continuously improving.

• Ensure Device Quality Team meets  global standards/principles with regards to organization, personnel, qualification, training, procedures, processes, performance, productivity

• Evaluate Quality performance (KPIs and Quality reporting) for Device Quality, proactively involved to enable progress on projects/initiatives as well as issues/Quality related escalations that might arise.

• Develop annual budget, revising forecasts to meet business needs and monitor/ control expenditures to ensure efficient use of company resources

• Standing member of PTQ Exec Team and Device Community acting as Quality Business Partner

• Accountable for Device Management Review of Quality

The Mindsets we're looking for

The successful candidate will have — and be passionate about encouraging others to adopt:

• A mindset of inclusivity

• A mindset of speaking-up

• A mindset of coaching others

• A mindset of focusing on outcomes

• A mindset of continuous learning

• A mindset of shared accountability

The Leadership Behaviors we're looking for:

• Act as a Visionary by helping co-create a bold, shared vision for the Area, with a clear sense of how it connects to the broader organization.

• Act as an Architect by establishing a framework for delivery of business objectives in collaboration with internal and external partners and fostering a diverse and inclusive culture, where people feel safe to collaborate, and experiment, in the interests of patients, and our Vision.

• Act as a Coach to colleagues in the Area, and across the wider organization, role-modeling coaching skills and engaging with empathy, trust, and a desire to help people move beyond their self-perceived limits and become the best they can be.

• Act as a Catalyst by connecting people, removing barriers and creating clarity, focus, and clear team accountabilities that will help accomplish ambitious goals.

Experience:

• Strong senior leader with business acumen in addition to senior device technical / quality knowledge; proven track record in Device Quality

• A strong expertise understanding of Medical Device Quality concepts per ISO13485,  21CFR820, and EU MDR

• Experience with Legal Manufacturer obligations of Medical Device

• Experience in Medical Device launch and commercialization

• Significant industry experience in a regulated industry, such as the medical device and/or the pharma/biopharmaceutical  industry

• A strong expertise  of quality assurance concepts, such as Good Manufacturing Practices (cGMP) & GSDP Good Storage & Distribution Practices, and GCP knowledge

• Evidence of your ability to develop employees through their lateral and/or promotional movement internally or externally

• Significant experience in leading teams in a matrix environment.

• Strong Quality and Compliance understanding

• Demonstrated VACC leadership behaviors, is inclusive and values a diverse workforce. Inspirational leader with compelling vision, strong system thinking, high authenticity, supporting the organization as servant leader and coach (VACC)

• Effective at building and maintaining constructive and effective relationships with internal and external stakeholders.

The expected salary range for this position is based on the primary location of South San Francisco, California is $340,000 to $400,000.  Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are provided. Relocation Benefits are provided.
http://yourlifeyourrewards.com

Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

Genentech is an equal opportunity employer,  and we embrace the increasingly diverse world around us.  Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage. 

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