Chapter Lead - External Advocacy (Director/Sr. Director/Exec Director)
Posted on: August 6, 2022
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
* Use of data analytics to eliminate waste from internal
misalignment of policy implementation and revisiting of policy
* Advancing internal compliance by shifting information flow to a
* 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
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
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
* 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
* 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
* 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
* 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
* 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
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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