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Lead Quality Assurance Manager
2 months ago
Position: Senior Quality Manager (R&D Medical Device)
Company: Vakulatech
Role Duration: 12+ months
Compensation: $70-80 per hour
Key Responsibilities:- Enhance the comprehension of medical device quality standards to support clinical development initiatives and regulatory frameworks, ensuring data integrity and patient safety.
- Collaborate with essential departments such as Regulatory Affairs, Safety, Clinical Operations, and Device Manufacturing to shape the quality strategy for medical device R&D.
- Serve as a subject matter expert in Quality & Compliance Audits, assisting in risk assessments and audit strategies for medical devices.
- Provide guidance to business stakeholders and study teams regarding quality oversight of outsourced IVD assays for various products, including the formulation of Quality Agreements.
- Advise Diagnostic Sub-Teams on R&D device quality matters.
- Work alongside study teams, including Therapeutic Area quality leads, to manage medical device quality challenges, vendor oversight, and CAPA processes.
- Offer direction on procedural development and review to ensure alignment with internal protocols and regulatory requirements for medical devices.
- Utilize metrics and other analytical tools to identify trends and gaps in medical device quality at a portfolio level, advising the business on necessary mitigation strategies.
- Collaborate with relevant functional areas to assess gaps, investigate, and resolve cross-portfolio medical device quality issues, supporting functions like Patient Safety and Clinical Operations in implementing Quality Improvement plans.
- Deliver timely, risk-based compliance advice to facilitate informed decision-making.
- Partner with key functional areas in the development and investigation of internal deviations or CAPAs.
- Engage in quality and cross-functional process improvement initiatives as assigned.
- Support key functions and study teams during regulatory inspections.
- Bachelor's or Master's degree with over 10 years of relevant experience.
- Extensive experience advising R&D businesses on medical device quality strategies.
- Familiarity with the application of IVD assays in clinical trials.
- Knowledge of GCP regulations and guidance, including ICH E6 R2.
- Expertise in IVD regulations, particularly IVDR.
- GCLP experience is advantageous.
- Comprehensive understanding of FDA and global regulations and guidance for medical devices, with the ability to apply them in an R&D context.
- Proven experience in a compliance-related advisory role.
- Recognized as an expert resource on various medical device compliance topics.
- Experience in the bio-pharma or diagnostics sector is required.
- Strategic problem-solving skills with a deep understanding of drug development processes.
- Exceptional verbal, written, and interpersonal communication skills, including the ability to present to senior leadership.
- Experience with CAPA management programs is preferred.
- Strong organizational and project management abilities.
