Job Description

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

As a Process Validation Coordinator, you are joining a dedicated technical project team focused on ensuring the highest quality standards for critical health authority submissions. This role offers a unique opportunity to cultivate strong collaborative relationships while driving process improvements and compliance across multiple departments. You will work in an atmosphere of openness and trust, leveraging your communication skills to manage vital documents that directly impact our strategic healthcare goals.

The Opportunity:

• You are coordinating assigned Process Validation (PV) study documents for projects and supporting vital Health Authority submissions.
• You are proofreading, editing, and compiling supporting data for PV protocols and reports to ensure accuracy, completeness, and consistency.
• You are coordinating the adjudication of reviewers’ comments with authors and Subject Matter Experts (SMEs), providing timely follow-ups to outstanding queries.
• You are performing compliance reviews of completed PV work to guarantee strict alignment with internal Quality standards and requirements.
• You are facilitating PV template creation and assisting in training cross-functional teams on workflows, timelines, and compliance requirements.
• You are communicating effectively with cross-functional project teams, presenting PV activities at department meetings, and resolving conflicts in a positive manner.
• You are utilizing appropriate IT solutions and tools to manage process knowledge and gathering key technical information to keep systems updated.

Who you are:

• You hold a Bachelor’s degree or higher and have 0-2 years of relevant work experience in the process validation area.
• You are experienced with process validation documentation requirements and possess excellent business acumen and solid judgment to work autonomously.
• You are a strong communicator with interpersonal skills that allow you to establish collaborative relationships, resolve conflicts positively, and influence without authority.
• You are a highly motivated self-starter equipped with strong project management skills to consistently achieve multiple tasks on time.
• You are highly adaptable and capable of handling multiple priorities, conflicts, and ambiguity effectively.

Preferred:

• You have hands-on experience authoring and/or editing process validation documentation.

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of San Francisco, CA is 72 600,00 - 134 800,00 USD Annual. 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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.