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Lead - External Advocacy North America (Director/Sr. Director/Exec Director)

Company: F. Hoffmann-La Roche Ltd
Location: Washington
Posted on: September 24, 2022

Job Description:

The Position

We are seeking a director level leader for our External Advocacy team.

Quality Policy & Advocacy:

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

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

    Lead, External Advocacy North America develops and delivers on innovative GMP/GDP regulatory pathways and/or streamlining of existing regulations in North America (United States, Canada) 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.

    Lead (External Advocacy, North America)

    The key responsibilities of this role are:
    • Develop and lead advocacy topics, related working groups and external interactions
    • Ensure 'right-to-operate' by guiding self-empowered matrix teams toward a customer- orientated, lean, end-to-end mindset.
    • Ensure matrix teams have the required proficiency to execute work packages, deliver their objectives and seek ways of continuously improving.
    • Advance the behavioral capabilities of the Network, by coaching matrix team members in new-ways-of-working approaches such as flow-to-work.
    • Partner and build relationships with 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.
    • Help the Area Enabling Team's implementation of the PTQ strategy, ensuring it is aligned with PT and Roche Pharma priorities.
    • Monitor industry trends, keep up to date with regulatory requirements and participate in company external influencing efforts
    • 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.

      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 job posting.

            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.

            Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.

            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.

Keywords: F. Hoffmann-La Roche Ltd, Washington DC , Lead - External Advocacy North America (Director/Sr. Director/Exec Director), Executive , Washington, DC

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