Roche

Regulatory Innovation & Sustainment Professional - Quality & Compliance

Roche$141K — $262K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent in a scientific or quality-related field.
  • Minimum 7 years in Quality & Compliance, Regulatory Affairs or Drug/Device Development.
  • Strong understanding of regulated environments and industry frameworks.
  • Skilled in analyzing complex quality data for executive reporting.
  • Exceptional verbal and written communication skills.
  • Continuous improvement mindset with a proactive problem-solving approach.
  • Ability to influence best practice adoption.

Responsibilities

  • Act as a trusted partner to senior stakeholders in global quality compliance.
  • Collaborate with global teams to enhance Quality & Compliance capabilities.
  • Monitor external trends and regulatory changes for readiness.
  • Identify continuous improvement opportunities and drive change initiatives.
  • Lead audits, inspections, and risk assessments to ensure compliance.
  • Ensure adherence to global regulatory standards related to GCP, GVP, and Medical Devices.
  • Optimize processes to achieve operational excellence.

Benefits

  • Comprehensive healthcare coverage.
  • Retirement savings plan options.
  • Opportunity for discretionary annual bonus based on performance.
  • Engagement in innovative regulatory practices.
  • Formative role in shaping the corporate Quality Management System.
Full Job Description

As a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatorys (PDR) Quality & Compliance capability, you will be accountable for creating and maintaining PDRs Quality Management System (QMS) framework. This includes fostering innovation, identifying and implementing continuous improvement opportunities and developing risk-based quality strategies.



The Opportunity
  • Act as a trusted partner to senior business stakeholders, leading or supporting cross-functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes.

  • Collaborate with global teams to mature and sustain PDRs Quality & Compliance capabilities.

  • Monitor external trends and regulatory changes to ensure ongoing readiness.

  • Identify opportunities for continuous improvement and drive strategic change initiatives.

  • Lead internal/external audits, Health Authority inspections, and risk assessments.

  • Ensure compliance with global regulatory standards including Good Clinical Practice / Good Pharmacovigilance Practice (GCP/GVP) and Medical Device related requirements, where applicable.

  • Optimize processes to enable operational excellence and maintain our license to operate.



Who You Are
  • You have a Bachelors degree or equivalent in a scientific or quality-related field.

  • You have a minimum of 7 years of experience in Quality & Compliance, Regulatory Affairs or Drug and/or Device Development, with a strong understanding of regulated environments, industry frameworks, data and digital systems.

  • Youre a strategic thinker and problem solver who thrives in a fast-paced, collaborative environment, driven by purpose, excited by innovation, and confident in influencing change across a complex organization.

  • You are skilled at analyzing complex quality data and translating these insights into clear, actionable executive reporting and strategic messages.

  • You possess exceptional verbal and written communication skills with proven ability to communicate and collaborate effectively across global/local matrixed teams and senior leadership.

  • You possess a continuous improvement mindset and a proactive approach to solving challenges, with the ability to assess end-to-end processes, identify inconsistencies, and improve process effectiveness and efficiency.

  • You can influence best practice adoption.


Preferred:
  • Experience with audits or inspections is a plus, but not essential.

  • Advanced degree in a scientific or quality-related field.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $141,100 - $262,100. 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

About Roche

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the largest pharmaceutical company in the world, and the leading provider of cancer treatments globally. The company also produces a range of diagnostic tests for medical professionals and patients. Roche was one of the first companies to bring targeted treatments to patients. In 2019, Roche had over 100,000 employees worldwide, and generated revenue of CHF 61.5 billion.
Learn more about Roche
Size
100,920 employees
Industry
NASDAQ

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