[Hiring] Affiliate Director, High quality Assurance @Precisionmedicinegroup

QuartzBio Overview:

QuartzBio (www.quartzbio.com) is a Precision Medication Intelligence Firm.  Our first-in-class Precision Medication AI Agent Platform allows autonomous knowledge ingestion and conversational insights throughout the precision drugs worth chain. Powered by a community of domain-specific AI brokers, our options amplify the efforts of operations, translational, informatics, and IT groups, utilizing AI-driven integration of biomarker, pattern, and medical knowledge to create a unified, scalable knowledge ecosystem. R&D groups can shorten time from knowledge to insights, analytics, and visualizations, accelerating research shut and time-to-market. Rework the way in which precision drugs groups work with 360° intelligence. 

Place Abstract:

We’re searching for a strategic and technically adept Affiliate Director of High quality Assurance (QA) to steer our QA operate in a dynamic, fast-paced surroundings. On this function, you’ll convey deep technical experience, notably in regression and efficiency testing for each normal and AI-enabled options of knowledge platform options. You can be answerable for shaping and executing a complete QA technique that ensures the supply of scalable, compliant, and high-quality software program merchandise.

This place is right for a seasoned QA chief with a ardour for constructing sturdy testing frameworks, driving innovation in high quality practices, and supporting the event of cutting-edge options within the life sciences and healthcare expertise house.

Key Tasks:

• Outline and execute a complete QA technique aligned with the wants of a SaaS platform within the life sciences area and the corporate’s broader enterprise goals, guaranteeing compliance with business laws and requirements.
• Lead the design and implementation of take a look at plans throughout purposeful, regression, efficiency, scalability, and AI/ML testing; oversee automated take a look at frameworks and CI/CD integrations.
• Guarantee sturdy validation of AI/ML fashions utilized in medical or scientific functions, together with bias detection, reproducibility, and efficiency benchmarking.
• Promote QA finest practices and foster a tradition of high quality throughout engineering, product, and operations groups.
• Collaborate with cross-functional stakeholders to embed high quality all through the PDLC and SDLC, and outline high quality necessities, validation methods, and testing timelines.
• Preserve and apply High quality Methods to make sure compliance with specs, regulatory requirements, and inner insurance policies.
• Lead inner audit readiness and assist exterior regulatory inspections (e.g., FDA, ISO).
• Act as a liaison between QA and different purposeful groups to align operational and high quality goals.
• Present strategic QA enter for brand new initiatives, product growth, and expertise switch.
• Handle a number of QA members, together with efficiency evaluations, teaching, coaching, mentoring, and profession growth.
• Talk high quality targets, metrics, dangers, and system efficiency to govt management.
• Monitor and report on high quality metrics, launch readiness, and threat assessments.
• Keep present with FDA, EU, and world regulatory requirements and guarantee organizational compliance.
• Oversee validation packages, together with planning, execution, and documentation of course of and gear validations.
• Handle provider {qualifications} and collaborate with procurement to make sure vendor compliance.
• Drive steady enchancment initiatives and implement cost-effective high quality enhancements.
• Consider and choose QA instruments, automation frameworks, and applied sciences; evaluation and approve take a look at methods, validation protocols, and high quality documentation.
• Keep knowledgeable on rising traits in high quality assurance, compliance, and testing applied sciences.
• Handle relationships with QA distributors, consultants, and third-party testing suppliers.
• Carry out different duties as assigned.

{Qualifications}:

• Bachelor’s diploma associated discipline and a minimal of 12 years of related work expertise in pc Science, Engineering, Life Sciences, cloud/infrastructure applied sciences, info expertise (IT) consulting/assist, techniques administration, community operations, software program growth/assist, expertise options.
• 12+ years of expertise in software program QA
• Minimal 5 years of expertise in managing groups.
• 6-8 years of expertise working in a customer-facing function and main initiatives.
• Deep understanding of SaaS structure, cloud platforms (e.g., AWS), and agile growth methodologies.
• Confirmed expertise with:
  • Regression and efficiency testing
  • AI/ML mannequin validation
  • Check automation frameworks
  • CI/CD pipeline integration and optimization
• Familiarity with GxP, FDA 21 CFR Half 11, GDPR, or different related compliance frameworks.
• Confirmed govt management with a strategic mindset and a powerful give attention to stakeholder engagement, buyer satisfaction, and vendor relationship administration.
• Distinctive communication abilities—each written and verbal—with demonstrated skill to current clear, persuasive, and well-organized info to numerous audiences.
• Expert in growing and delivering compelling enterprise proposals and enterprise instances, each orally and in writing.
• Skilled in high quality administration techniques (QMS) and sustaining audit readiness throughout operations.
• Sturdy analytical and problem-solving skills, with a stable understanding of metrics to forecast and handle undertaking value, schedule, effort, and high quality.
• Adept at main change by establishing efficient constructions and processes to make sure clean and profitable implementation.

Management expectations:

• Observe Firm’s Precept and code of ethics on a day-to-day foundation.
• Lead the crew in understanding and embodying the corporate’s core values.
• Present clear and compelling imaginative and prescient for the group and talk it successfully to their groups and stakeholders.
• Suppose strategically and develop plans and initiatives to attain the group’s targets, whereas aligning them with the corporate’s general technique.
• Capability to draw, develop, and retain prime expertise throughout a number of groups or features, making a tradition of studying and development, figuring out abilities gaps and offering growth alternatives.
• Capability to grasp and admire the wants and views of their crew members, making a constructive and inclusive work surroundings.
• Construct robust relationships with crew members, stakeholders, and different leaders within the group, fostering collaboration and teamwork.
• Capability to encourage and encourage their crew members, encouraging them to carry out at their finest and obtain their full potential.
• Successfully handle the efficiency of their crew members, offering suggestions, setting expectations, and holding people accountable for his or her outcomes.
• Successfully handle conflicts that come up inside their crew or with different groups, working to seek out options that meet everybody’s wants.
• Delegate duties and tasks to their crew members, empowering them to tackle tougher work and develop their abilities.
• Acknowledge and reward the contributions of their crew members, making a constructive and supportive tradition that values and celebrates success.
• Navigate cultural variations and work successfully with crew members from numerous backgrounds, selling inclusion and variety inside their crew.
• Collaborate successfully with different leaders within the group, working collectively to attain shared targets and drive enterprise success.