Roche Holdings Inc Hiring for Global Head End to End External Quality at South San Francisco, CA  Full Time

Job Summary

Reporting to the Head of PTQ, and a member of the PTQ Enabling Team, the External Quality Operations Area Lead, will play a crucial role in supporting PTQ 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, the External Quality Operations Area Lead will collectively, with peers on the Enabling Team, shape and execute Global Quality and Compliance strategies in alignment with the PT strategy, and ensure PTQ delivers its commitment to the Pharma Vision.

The External Quality Operations Area Lead holds global and end-to-end responsibility for External Quality Area and, 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).

Area Overview:

End-to-end External Quality Operations Area Lead is accountable for quality and compliance for all sourcing of incoming raw materials, manufacture and supply performed by third parties (CDMOs) and distribution quality from sites to affiliates/patients, including EU certification and Chugai collaboration.

This includes quality oversight, quality agreement, inspection readiness and positive outcome, operational product quality management.

Additionally, End-to-end External Quality Operations Area Lead would be operationally responsible for:

• Oversight and management of batch release in accordance with Global HA standards for clinical and commercial products manufactured in the external network, including EU certification globally.

• Partnering with procurement for managing suppliers in a compliant and cost-effective way and looking for opportunities with external partnerships to build synergies, and brings meaningful insights into the organization that catalyze both strategy and service development.

• Ensuring effective quality management of significant product quality issues, including decision support for Health Authority and Field Action decisions.

• Ensuring rapid, successful, and seamless transfers of production processes across external manufacturing networks to ensure supply resilience and network efficiency.

Key responsibilities include:

• Lead an empowered area with a wide range of expertise (coming from multidisciplinary functions) to ensure “Right to Operate” by implementing a Quality and an End-to-End mindset.

• Orchestrate priorities of our changing portfolio towards resilient supply and launch excellence in collaborations with PT functions.

• Actively partner with respective stakeholder/s to drive One Quality Voice and ensure strategic alignment across multiple Functions

• Manage the external network with a continuous improvement mindset for key Quality and GMP operational aspects.

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

• Budgeting and Financial Performance: Accountable for overall budget and financial performance of assigned area and jointly responsible for performance of PTQ as a whole.

• Standing member of PTQ ET and PTS LT acting as a Quality Business Partner

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

• Ensure area operations meet global standards/principles with regards to organization, personnel, qualification, training, procedures, processes, performance, productivity

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

Qualifications:

• Significant industry experience in pharma / biopharma business including experience in multiple technical platforms (bulk drug substance, steriles, devices and combination drug products) and product lifecycle.

• Significant operational experience such as PT site head/Quality Site Head.

• Experience with working in global matrix organizations.

• Strong Quality and Compliance understanding.

• Demonstrated VACC (visionary, architect, catalyst and coach) 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.

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.

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

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Roche is an Equal Opportunity Employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.