Digital Quality & GxP Manager

How This Role Makes a Difference

We are seeking a Digital Quality & GxP Manager to join our Quality team and help to support Quality at Care Access and our parent company Reify Health. This role will help to manage compliance risk and provide practical guidance on GxP quality at all stages of the software product lifecycle.

The successful candidate will have hands-on experience implementing GxP compliance at a fast-paced technology company and will support quality for both internal and external software products, systems and AI products. Digital Quality & GxP Manager must build and maintain collaborative relationships with internal and external stakeholders to accomplish key business objectives across departments.

How You'll Make An Impact

• 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
• Development and maintenance of digital/software components of quality management systems, including AI quality management systems
• Proactively monitor systems and processes to ensure 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

The Expertise Required

• Demonstrated leadership experience in implementing compliance programs within the software industry. Project management experience preferred.
• 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

Certifications/Licenses, Education, and Experience

• Minimum Education:
• Certifications in GxP quality, computer systems validation processes or quality systems management preferred.
• Minimum Experience:
• 3+ years of experience implementing GxP standards and advising on matters of quality compliance at a SaaS company, including GxP systems validation

How We Work Together

• Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
• Travel: This is a remote position with travel requirements up to 40%. Occasional planned travel may be required as part of the role.
• Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

Pay and benefits

The expected pay range for this role is $110,000 - $140,000 USD per year for full time team members.

Benefits & Perks (US Full Time Employees)

• 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

Mandatory Employer Disclosures

• Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
• Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
• Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
• Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
• Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29-38 of Title 28 of the Rhode Island General Laws.

Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.

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Diversity & Inclusion

• We work with and serve people from diverse cultures and communities around the world.
• We are stronger and better when we build a team representing the communities we support.
• We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

Care Access is unable to sponsor work visas at this time.