Strategic Quality Partner

8+ years

Not Disclosed

Basel Remote Tucson

10 Feb. 14, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Strategic Quality Partner
Location: Tucson, Arizona, United States
Category: Quality
Job Id: 202411-129076

Position Overview:

Roche is looking for a Strategic Quality Partner (SQP) to join their Product Development Quality team. The role involves fostering effective partnerships with Development Project Teams, ensuring project milestones are met on time, and maintaining alignment with global quality standards. As an SQP, you will be responsible for ensuring quality throughout software development, particularly for medical device software (SaMD), and driving the effective adoption of quality-related processes across the company. You will collaborate with both internal and external stakeholders, championing quality and risk management to enhance project execution.

Key Responsibilities:

Project Management & Leadership:
- Act as the single point of contact for project teams (New Product Development/Product Change) and partner with Design Quality Partners (DQP) to ensure proper documentation and milestone deliverables.
- Lead strategic decision-making in project execution, facilitating discussions in project team meetings.
Quality & Risk Management:
- Ensure consistent interpretation and implementation of global quality requirements across customer areas (CAs).
- Drive awareness and adoption of risk management processes, enabling risk-based decisions in quality-related matters.
Stakeholder Engagement & Knowledge Sharing:
- Foster communication with internal and external stakeholders, ensuring feedback loops and information flow for milestone reviews.
- Promote continuous improvement in Pre-Market Quality through knowledge management and sharing lessons learned.
Regulatory Compliance:
- Ensure that development project plans align with the D&D module and include necessary deliverables to ensure safe and compliant solutions.
- Support internal and external audits, working to resolve issues (e.g., CAPA, NC).
Innovation & Change Management:
- Promote a culture of innovation within Product Development Quality, R&D, and other functions.
- Foster an agile mindset and drive organizational change in support of collaboration and adaptability.

Who You Are:

Education:
- Bachelor's degree in science, business administration, or a related field (MBA or advanced degree is a plus).
Experience:
- At least 8 years of experience in the diagnostics or a related industry.
- Strong background in software development, specifically in medical device software (SaMD).
- Familiarity with regulations such as ISO 13485, IEC 62304, MDR, and others.
Skills:
- Solid understanding of business and financial acumen.
- Excellent communicator with strong presentation and negotiation skills.
- Experience leading cross-functional teams and driving change within organizations.

Location:

Tucson, Arizona
Relocation benefits are not available for this position.

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Strategic Quality Partner

Job Description

Position Overview:

Key Responsibilities:

Who You Are:

Location:

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