The Position

Location: Location flexible within the Roche network. Any major pharma sites incl. Affiliates, Oceanside, Vacaville, Hillsboro, San Francisco, Basel, Kaiseraugst, Penzberg, Mannheim, Mississauga, Shanghai, Singapore

Quality Policy and Advocacy (QP&A) 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.

QP&A 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 Quality Policy Network Lead reports to the International External Policy Chapter Lead within QP&A and plays a key role in advancing Roche’s product and pipeline strategies by partnering internally and externally to protect and strengthen our right to operate. The leader will be responsible for driving global regulatory convergence and promoting harmonization on cGMP/cGDP topics across international 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. The leader will be responsible for establishing a sustained regulatory intelligence method enabling the collection, analysis and dissemination of regulatory intelligence information and monitoring and assessing relevant industry benchmarking efforts across external policy in compliance with current GMP and Genentech Quality policies and standards.

Primary Responsibilities:

• Collaborate and build relationships with partners to deliver on strategic priorities

• Establishes and maintains relations and leadership responsibilities in major industry associations

• Manages and has command of all Roche regulatory policy activities including oversight on requirements, legislations and regulatory environment.

• Identify cross-region priorities, develop outreach strategies, and drive their execution.

• Act as a strategic quality and compliance policy partner to stakeholders in PTQ and PT.

• Advance behavioral network capabilities, by realizing new-ways-of-working approaches.

• Drive global regulatory convergence and promote harmonization on GMP/GDP topics.

• Assess impact of regulatory guidance, coordinate response to Health Authorities.

• Cover conference and key public meetings and cascade insights as appropriate.

• Identifies and leads regulatory policy and strategic initiatives that will lead to a more favorable regulatory environment and enhance Roche’s ability to be nimble in a changing regulatory environment.

• Builds and maintains relationships based on trust and respect with internal and external stakeholders with the purpose of creating effective collaboration.

• Monitors and analyzes regulatory intelligence across the Region to identify and anticipate trends. Serves as the expert on the Region’s regulatory intelligence trends.

• Provides subject matter expertise, supporting country Affiliates in influencing efforts with local regulators.

• Builds influencing and advocacy knowledge and capacity, and empowers Region and Affiliate representatives to influence regulatory policy through workshops, training, mentoring, coaching, and communications. Designs and executes relevant and effective learning units and supporting materials, as well as tools and messaging for use within the Region and its Affiliates.

• Actively support all aspects of QP&A's activities, including developing, summarizing and editing content for articles and/or publications.

Knowledge/Skills/Competencies:

• Collaborative, highly motivated individual who takes responsibility and achieves outcomes.

• Outstanding ability to develop effective relationships, influence, solve problems and resolve conflicts in a proactive and constructive manner.

• Strong interpersonal and influencing skills, and the ability to effectively communicate - both verbal and written - with partners across at all levels

• A rapid learner with an ability to absorb, analyze and dissect large amounts of information with the ability to understand complex unstructured data, and relate it to both internal and external business drivers

• An independent self-starter, detail oriented and strong critical thinker.

• Superior ability to partner internally and externally, collaborating on strategic priorities.

• Ability to manage, drive and execute multiple projects independently.

• Be an inclusive, active and visible change agent, fostering a curious and open mindset to new opportunities, learning and continuous improvement.

• Create an open and inclusive atmosphere, providing and receiving constructive feedback.

• Resilience and ability to deal with ambiguity.

• Exceptional collaboration skills; able to quickly and consistently establish rapport and collaborate effectively with team members and partners.

• Person of high integrity who can be trusted with important information.

Relocation benefits are not available for this role.

The expected salary range for this position based on the primary location of Vacaville, CA is:

• SE8: $140,700 - $261,300
• SE9: $163,100 -$ 302,900
• E10: $189,200 - $351,400.

Actual pay will be determined based on experience, 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.

Benefits

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.