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Director, R&D Diagnostics Quality

United States - California - Foster CityQualityRegular
sich bewerben

Arbeitsbeschreibung

We are seeking a Director, R&D Diagnostics Quality to provide strategic quality leadership and regulatory oversight for diagnostic and companion diagnostic (CDx) programs across our global R&D portfolio. This role serves as a trusted advisor to R&D and Precision Medicine teams, applying a risk-based approach to partner and supplier oversight, clinical evaluations, and device governance to ensure compliance with global medical device and GxP regulations.

The Director partners cross functionally to advance diagnostic quality systems, support regulatory inspections, and ensure investigational devices meet Gilead standards while protecting patient safety and data integrity. You will join our high-performing team to support Research and Development functions and be responsible for providing quality advice, direction, and leadership for the conduct and oversight of Medical Device regulated activities in R&D.

You will partner closely with business functions in applying a risk-based approach to key activities which include vendor oversight, product development, clinical evaluations, performance evaluations, and general clinical governance for medical devices with a focus on diagnostics/CDx. You will be a key advisor for diagnostic product study teams and a key member of the G Ecosystem framework for diagnostics. You will work closely with functions across Quality Systems and device governance to ensure investigational devices meet Gilead standards and comply with regulations.

The Director will collaborate cross-functionally to elevate quality systems, compliance frameworks, and patient-centric outcomes across a global R&D portfolio in Oncology, Virology, and Inflammatory Disease. Specifically, you will partner with other functions to execute the R&D quality management system strategy for diagnostic medical devices. Utilizing expert knowledge in this role you will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization.

The ideal candidate will have experience in global quality systems across the pharmaceutical, biotech, and medical device sectors and advanced expertise in GxP compliance, including applied experience with FDA 21 CFR 820/812/4, ISO 13485, ISO14971, EU MDR/IVDR, ICH, and GCPs.

Key Responsibilities:

  • Partner with Research and Development Leadership to evaluate the current state of quality and potential risk for IVD use within Precision Medicine studies at Gilead.

  • Serve as the resident R&D compliance expert for diagnostic R&D programs, spanning clinical trials with investigational devices across all Gilead therapeutic areas; may provide quality oversight more broadly, including combination products and laboratory quality.

  • Ensure appropriate quality oversight for precision medicine programs, including partners, and service providers

  • Lead the development of diagnostic quality management strategies to ensure compliance with the evolving regulatory landscape.

  • Advance the understanding of US/EU Device regulation to support of R&D programs and the regulatory framework to ensure data integrity and patient safety.

  • Develop and monitor KQIs for critical to quality IVD areas that need improvement and/or key risks reportable through quality management review.

  • Lead Quality investigations, RCA, CAPA oversight, and remediation planning for device-related issues. Support Device centric Audits, regulatory agency inspections, and risk assessments.

  • Strategic partner for R&D functions including Diagnostics, Regulatory Affairs, Patient Safety, and Clinical Operations, responsible for advising on diagnostic quality risks and mitigations.

Minimum Required Education and Years of Experience

  • PharmD/PhD with 8+ years’ relevant experience OR

  • MA/MS/MBA with 10+ years’ relevant experience OR

  • BA/BS with 12+ years’ relevant experience.

Preferred Qualifications, Knowledge & Other Requirements

  • Advanced degree in life sciences or related field with extensive experience in the biopharma industry, including extensive experience working in quality, compliance, or a related field.

  • Experience working in medical device quality; must have previous experience in a diagnostic quality role.

  • Deep Understanding on the use and application of medical devices in clinical trials and regulatory submissions (IDEs, NDA, 510(k)

  • Understanding of FDA + Global regulations and Guidance for medical devices, and how to apply them in an R&D setting.

  • Recognized expert in regulations and application including FDA 21 CFR Part 820/812/4, ISO 13485, ISO14971 EU MDR/IVDR, ICH.

  • Track record of successful development and launch of medical devices, inspection readiness, QMS design, and resolution of compliance issues.

  • Good presentation, communication and executive engagement skills. Experience in Health authority interaction with FDA, EMA, MHRA and Notified Bodies is a plus.

  • Proven ability to lead projects and cross-functional programs and influence without authority in matrixed environments

  • Certifications from American Society for Quality (ASQ), Six Sigma Black Belt, Medical Devices from RAPS such as: RAC-Devices; RCC-MDR or RCC-IVDR. are a plus.

  • Expert knowledge of GxP regulations for Medical Devices and Diagnostics/CDx and Good understanding of CAP/ CLIA /ICH requirements.

  • Sponsor experience in a quality role supporting GxP clinical builds involving investigational devices highly preferred.

  • Experience in laboratory quality such as GLP/ GCLP is preferred.

  • Strong leadership presence with demonstrated ability to lead and influence programs, projects and/or initiatives.

  • Strong interpersonal, communication, and organizational skills

  • Strong negotiation and conflict resolution skills.

  • When needed, ability to travel.

People Leader Accountabilities

  • Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

  • Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

  • Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem