Quality Manager

The Quality Manager plays a pivotal role in Slope, contributing to our regulatory industry best practice compliance posture. This position involves maturing, maintaining, and supporting compliance processes while maintaining independent oversight of in-scope business units. The ideal candidate will be responsible for ensuring compliance with all relevant regulations, standards, and guidelines in our industry. This role requires a keen understanding of regulatory requirements, excellent communication skills, and the ability to collaborate across departments to implement and maintain quality systems. The Quality Manager will play a critical role in safeguarding our company's reputation and ensuring the delivery of safe, effective, and compliant products or services to our customers.

‍

• Develop, implement, and maintain compliance strategies and quality systems to ensure adherence to applicable regulations and standards for developing validated systems and providing data management services in a regulated industry.
• Monitor changes in regulations and proactively assess the impact on our operations, products, and services.
• Provide guidance and support to cross-functional teams on regulatory requirements, quality standards, and compliance issues within area(s) of responsibility.
• Conduct internal audits and assessments to evaluate compliance with regulatory requirements and identify areas for improvement.
• Collaborate with external partners, regulatory agencies, and industry organizations to stay informed about best practices and regulatory developments.
• Work with the Senior Director of Quality to lead regulatory inspections and customer audits, ensuring readiness and facilitating interactions with auditors.
• Manage documentation and records related to regulatory compliance activities, ensuring accuracy, completeness, and accessibility.
• Investigate and resolve compliance issues, deviations, and non-conformances in a timely manner.
• Develop and deliver training programs to educate employees on regulatory requirements, quality standards, and compliance procedures.
• Drive continuous improvement initiatives to enhance regulatory compliance processes and efficiency.
• Ensure data integrity and data quality are core elements of our validated platform.
• Share knowledge and collaborate with other business units to ensure Quality is a core component of all products and services.
• Other duties as assigned.

Education

• Bachelor's degree in a relevant field such as Regulatory Affairs, Quality Assurance, a degree in a related scientific discipline, or other relevant work experience.

Experience

• 5+years of experience managing a quality system (e.g., ISO 9001, ISO 13485) for validated computer systems within a GxP setting, adhering to regulations and standards (e.g., 21CFR Part 11, GAMP 5).
• Minimum 1 year experience operating a quality management system in a growth-stage company.
• Minimum 2 years’ experience in audit engagement and management or other relevant experience.

Knowledge, Skills & Abilities

• Excellent analytical, problem-solving, and decision-making skills.
• Effective communication and interpersonal skills, with the ability to collaborate and influence across different levels of the organization.
• Detail-orientation with a focus on accuracy and compliance.
• Proven ability to manage multiple projects simultaneously and meet deadlines.
• Ability to work within a fast-paced environment.
• Knowledge of regulatory requirements and standards applicable to the company’s products and services.
• Knowledge of industry-specific software and tools for regulatory compliance and quality management.

Preferred Qualifications

• Advanced degree and certification in quality management (e.g., ASQ, GxP)
• Experience with Security and Privacy frameworks such as NIST 800-53, CIS, ISO 27001 are a plus
• Familiarity with agile software development methodologies
• Technical experience with software development practices, processes, and tools

Slope drives operational excellence for highly complex, sample-intensive clinical trials. Its clinical trial execution platform transforms chaotic clinical supply chains into protocol-specific operational workflows for sponsors, CROs, labs, and clinical research sites. Through Slope’s clinical inventory, sample management, and data-driven resupply solutions, the platform enables stakeholder collaboration, real-time visibility, traceable chain of custody, and risk mitigation. The results are improved trial outcomes including boosting patient enrollment and retention, reduction of supply waste, and adherence to study protocols, timelines, and budgets.

Slope has a fun, high-energy, fast-paced environment full of motivated, purpose-driven employees who practice our core values on a daily basis:

1. Patients are paramount
2. Better, faster, stronger
3. Driven by data
4. Job done, have fun
5. Get Sloped!

• Health insurance
• Dental and vision coverage
• Flexible spending accounts
• Healthcare savings accounts
• Employee-funded supplemental life insurance
• Employee-funded short and long-term disability insurance
• 401(k) plan
• Nine paid holidays
• 15 PTO days
• Annual home office stipend