Open Positions

Manager, Quality & Compliance, Audits (Eastern US/Midwest US Remote)


The Manager, Quality & Compliance, Audits will work with department leadership to formulate and drive the vision for quality and compliance and assist in developing, executing, and maintaining Anju’s Quality Management System company-wide. The Manager’s primary focus will be to provide leadership in the areas of internal/external audits and internal information requests. The Manager will host client audits and conduct internal and vendor audits, as well as coordinate resulting corrective action activities. As such, the Manager will be well versed in Anju’s policies, procedures, and work instructions, and be able to communicate effectively across all levels within the organization on a wide variety of topics with diplomacy and tact. The Manager will lead all audit activities needed to assure the successful execution of Anju’s regulatory compliance programs including FDA, ICH-GCP, 21 CFR Part 11, General Data Protection Regulation (GDPR), other regulations involving privacy and data protection, and additional applicable international regulations. Additionally, the Manager will be responsible for ensuring audits, customer driven requests, and internal questions do not impact the department’s efficiency and ability to complete meaningful work.


Highly professional; excellent work ethic; commitment to high quality standards, attention to detail, excellent communication, interpersonal, and presentation skills; strong planning and organizational skills, leadership ability and proven talent for seeking and implementing solutions; excellent time management skills; methodical work approach but can be flexible; ability to multi-task; self-starter; highly dependable; ability to work independently as well as within a collaborative, collegial, multidisciplinary environment.


  • Ability to act firmly and responsibly to ensure all compliance and quality issues are noted and addressed, including analyzing findings and making recommendations for resolution
  • Possess the ability to promote quality achievement and performance throughout the organization
  • Ability to liaise with customers and auditors to ensure compliance with customer’s specifications and the execution of corrective action when required
  • Comfortable interacting with auditors. Able to take a lead role in client audits
  • Ability to work within a team, establish direction, and motivate, and inspire team members
  • Must have excellent strong interpersonal skills with the ability to successfully collaborate with peers and cross-functional teams in order to achieve defined goals
  • Excellent presentation skills in small and large group situations paired with an understanding of appropriate communication methods within all organization levels. Must be able to clearly present to both technical and non-technical audiences
  • Must be highly skilled in both written and verbal communication
  • Solid knowledge of industry standards in software validation, qualification, testing methodologies
  • Experience in developing, documenting, and implementing procedures and work instructions
  • Exercise sound judgment and possess excellent organizational skills
  • Excellent oral and written communication skills


  • Execute Anju’s overall audit program including internal audits, vendor audits, hosting of client audits, and hosting regulatory inspections. Prepare external audit responses and follow-up of supporting documentation and proactive corrective action status reports to clients.
    • Responsible for all client, internal, and vendor audits
    • Facilitate/host all Anju customer audits
    • Perform internal audits for adherence to policies/SOPs/regulations/project specifications
    • Conduct vendor audits (virtual, remote, paper)
    • Audit and maintain annual vendor SOC reports and certifications
    • Develop/manage audit plans
    • Facilitate scheduling of audits
    • Prepare plans, presentations, and verify and/or process NDAs
    • Prepare and manage document portal
    • Respond to/manage responses to audit reports and findings
    • Manage associated CAPAs and provide support
    • Maintain metrics and provide reports to management
  • Act as subject matter expert to process internal and external requests for information
    • Manage all information requests coming into the department
    • Maintain metrics and provide reports to management
    • Maintain metrics and provide reports to management
  • Inform department leadership of any non-compliance incidents or regulatory compliance issues which may arise internally or with customers or vendors
  • Participate in Quality & Compliance Committee (QCC) activities as a committee member; assist QCC Chair with preparation and coordination of meetings, agendas, minutes, presentation delivery, and action items. Work with Chair and QCC to ensure compliance adherence across the organization
  • Help ensure all assigned divisions and departments have documented procedures and work instructions in place for all critical functions
  • Work within department leadership team to gather, analyze, and report of Anju Quality Metrics
  • Work within department leadership team to conduct internal investigations of compliance issues
  • Interface with all levels of staff and management to successfully maintain Quality System documentation, departmental policies, best practices, and corrective & preventative action process.
  • Stay current with changes to GxP, 21 CFR Part 11, HIPAA, GDPR, and other regulations that impact Anju’s core business and products
  • Mentor Quality & Compliance staff
  • Other duties as assigned


  • Must have a degree level education in a relevant field plus 5+ years of industry experience in an FDA regulated or formal quality system environment
  • Background in quality management and regulatory compliance in pharmaceutical, clinical, or biotech software/computer control environments, experience with internal controls, risk assessments, auditing, corrective and preventive action, and change management
  • Strong knowledge of GCPs, FDA regulations, quality assurance concepts, SOPs, and auditing techniques required. Knowledge of 21 CFR Part 11, GxP, GDPR, and privacy regulations preferred
  • Certified auditor with experience conducting audits of Quality Systems and hosting quality system audits.
  • Proficient with MS Office applications. Prior experience with quality management system software and/or software development in a regulated industry a plus.


The Department Head has the discretion to hire personnel with a combination of experience and education which may vary from the above listed qualifications.


Please submit resume and cover letter to:

Job Type : Full-time

Location : US

Salary : Based on experience

Anju Software is an Equal Opportunity Employer. Anju Software provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. Anju Software complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.

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