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Chapter Lead - External Advocacy (Director/Sr. Director/Exec Director)

Company: Genentech
Location: Oceanside
Posted on: August 6, 2022

Job Description:

The Position

Quality Policy and Advocacy assures supply of quality medicines to patients by championing GMP compliance sustainability across the Roche Pharma network and delivering on GMP regulatory strategies for successful pipeline launch and market access. Quality Policy and Advocacy partners internally to protect and strengthen Roche's "right to operate" and engages externally to foster Health Authority confidence and strategic industry collaboration.

Quality Policy and Advocacy is responsible for:

* One interpretation of regulatory policy to enable consistent risk tolerance and provide a single source of truth for PQS implementation

* Use of data analytics to eliminate waste from internal misalignment of policy implementation and revisiting of policy interpretation.

* Advancing internal compliance by shifting information flow to a collaborative discussion

* Strengthening Roche's position for external advocacy and influencing through increased engagement with Roche SME's to enable effective and efficient delivery of Roche's product portfolio to our patients.

The External Advocacy Chapter advances Roche's product and pipeline strategies by evaluating GMP/GDP regulatory information and directly influencing Health Authority regulations and industry standards via interactions with industry groups, Health Authorities and Government Affairs. Work Packages include: External Relations, Regulatory Intelligence and Policy Position.

Chapter Lead, Emerging Markets & Convergence is accountable for driving global regulatory convergence and promoting harmonization on GMP/GDP topics across emerging markets by collaborating with internal and external partners and stakeholders including but not limited to Roche affiliates and policy teams, government associations, health authorities and industry groups.

Chapter LEAD, Emerging Markets & Convergence (External Advocacy)

The key responsibilities of this role are:

* Hold end-to-end accountability for the Chapter team members' ability to deliver.

* Ensure 'right-to-operate' by guiding a self-empowered team toward a customer- orientated, lean, end-to-end mindset.

* Ensure the Chapter team members have the required proficiency to execute work packages, deliver the Chapter's objectives and seek ways of continuously improving.

* Advance the behavioral capabilities of the Network, by coaching Chapter team members in new-ways-of-working approaches such as flow-to-work.

* Partner and build relationships with other Chapter Leads to align on strategic priorities, accelerate decision-making, ease bottlenecks, and to support each other

* Act as a strategic partner to stakeholders in PTQ and PT in support of organizational priorities.

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

* Optimize and protect our new, flat, operating model, and continually identify organizational efficiencies.

* Help the Area Enabling Team's implementation of the PTQ strategy, ensuring it is aligned with PT and Roche Pharma priorities.

* Help the Area Enabling Team meet the demands of today, and drive preparation for the future in terms of skills, capabilities and technologies.

* Boldly advance diversity, equity, and inclusion so that people feel safe to learn, to experiment, to challenge, to contribute autonomously - and safe to be themselves.

* Enable talent flow in collaboration with other Chapter Leads, evaluating business requirements and generating solutions for succession planning and talent management.

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 Chapter, with a clear sense of how it connects to the broader organization.

* Act as an Architect by 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.


* Twelve years' experience in a regulated industry, such as the pharma/biopharmaceutical or medical device industry with 7 years' working in Quality, Compliance, Regulatory and/or Validation.

* A strong understanding 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.

* Experience in multiple manufacturing technologies and product lifecycles is desirable

* BA or BSc degree or equivalent in life sciences, Pharmacy or related a related scientific discipline.

As this position is part of a global organization, international business travel will be required depending upon the business location of the successful candidate and ongoing business activities.

Relocation benefits are available for this role.

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.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Keywords: Genentech, Oceanside , Chapter Lead - External Advocacy (Director/Sr. Director/Exec Director), Executive , Oceanside, California

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