Strategic Quality Partner Product Development Quality

5 days ago

Carlsbad, United States Roche Holdings Inc. Full time
About the Role

We are seeking a highly motivated Strategic Quality Partner to join our Product Development Quality organization at Roche Holdings Inc.

As a Strategic Quality Partner, you will be responsible for ensuring effective partnerships with Development Project Teams, driving project acceleration, and ensuring no delay in milestones and project execution.

Key Responsibilities
  • Act as a single point of contact within project teams (New Product Development / Product Change) and partner with Design Quality Partners (DQP) to decide efficient and effective documentation of milestone deliverables.
  • Partner with internal and external stakeholders across the value chain to incorporate learnings in the development process.
  • Ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs) and incorporate lessons learned from all areas of quality across Customer Areas (CA) into project support.
  • Ensure development project plans contain the right deliverables according to D&D module to deliver safe and compliant solutions.
  • Support internal and external audits and partner to ensure effective resolution of issues (e.g. CAPA, NC).
  • Drive awareness and adoption of the Risk Enabler inside and outside of Global Q&R decision making; prepare and enable risk-based decisions.
  • Advance the work of the organization by continuously improving knowledge management within Pre Market Quality, fostering the effective sharing and retention of valuable knowledge and expertise.
  • Ensure effective change management in Product Development Quality, R&D and other functions, while fostering a culture of innovation and continuous improvement, nurturing a creative and problem-solving mindset throughout R&D, Product Development Quality and other functions.
Requirements
  • Bachelor's degree in science, business administration or a related field. MBA or advanced degree is considered an advantage.
  • + 8 years of experience in the diagnostics industry or a related field in business-related functions.
  • Strong business and financial acumen with an enterprise mindset with scientific and technical background with sound product knowledge.
  • Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, GDP, GMP, others) and demonstrated thorough E2E understanding for lifecycle management.
Leadership
  • Pragmatic decision maker with the ability to move forward without a perfect solution.
  • Excellent communicator with strong presentation, and negotiation skills. Agile mindset and demonstrate new ways of working.
  • Experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change.
  • Inspire the organization to think in terms of impact and outcomes rather than tasks and serve as a role model, exhibiting behaviors that support the transition to a new operating model emphasizing agility, collaboration, and adaptability.
Location

Located in Carlsbad, California. Relocation benefits are available for this position.

The expected salary range for this position based on the primary location of Carlsbad is $108,800 and $230,000. 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.

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