Digital Quality Manager – GxP

Job not on LinkedIn

🕒 October 14

🇺🇸 United States – Remote

💵 $110k - $140k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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CARE

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1945

🍽️ Food & Beverage

🏥 Healthcare

📦 Logistics

💰 Grant on 2021-11

Food & Beverage • Healthcare • Logistics

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

📋 Description

• Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies • Prepare for and support external regulatory audits • Lead internal or vendor audits related to maintaining GxP and regulatory compliance • Develop and maintain digital/software components of quality management systems, including AI quality management systems • Proactively monitor systems and processes for compliance with standard operating procedures, audit compliance, and industry best practices • Review key vendors for compliance with digital quality requirements • Train and educate internal stakeholders on quality processes and best practices • Perform other tasks and special projects assigned by quality leadership • Build and maintain collaborative relationships with internal and external stakeholders across departments • Travel up to 40% as required

🎯 Requirements

• Demonstrated leadership experience in implementing compliance programs within the software industry • Experience with Good Clinical Practice is required • Demonstrated experience with SaaS application and agile product development methodology • Excellent communication and interpersonal skills • Strong analytical skills with the ability to effectively define business issues and recommendations • High attention to detail and organizational skills • Technical proficiency and understanding of data management in healthcare or clinical trial spaces • Highly detail-oriented with strong time management skills to manage multiple deadlines • Ability to work with minimal supervision and manage multiple priorities in a fast-paced environment • 3+ years of experience implementing GxP standards and advising on matters of quality compliance at a SaaS company, including GxP systems validation • Certifications in GxP quality, computer systems validation processes or quality systems management preferred • Must be able to work remotely within the United States • Care Access is unable to sponsor work visas at this time

🏖️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays • 100% Employer paid medical, dental, and vision insurance plan options • Health Savings Account and Flexible Spending Accounts • Bi-weekly HSA employer contribution • Company paid Short-Term Disability and Long-Term Disability • 401(k) Retirement Plan, with Company Match