CAREERS

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Come join us!

 

At Anju Software, we are looking for team members that share the passion and commitment to create the best product solutions available within the Life Sciences Software Sector.

If you enjoy a fast-paced collaborative work environment, check out our positions available below.  Please send a cover letter and resume to Careers and specify the desired open position and include the code following the position title.


OPEN POSITION:

Director of Quality & Compliance (FTLD-2020-14)

Position Summary

The Director of Quality & Compliance will work within the team providing leadership and support in the areas of quality management system and compliance activities. Work with department leadership to formulate and drive the vision for quality and compliance. Assist in leading the Quality & Compliance Committee. Oversee the implementation and monitoring of processes to ensure high quality and compliant deliverables at assigned Division(s). Ensure quality and reliability of products and services, provide support and expertise in achieving regulatory compliance and customer satisfaction, develop and maintain internal policies and procedures and ensure their compliance with FDA, ICH-GCP and other applicable international regulations for the conduct of clinical development programs. Review validation deliverables of Anju’s core application developments and customer-specific developments. Serve as primary contact for Regulatory and standards issues with internal and external customers. Facilitate and conduct client, vendor and internal audits and coordinate corrective action activities.

Personal Qualities:

Excellent work ethics; commitment to high quality standards, attention to detail, excellent communication and presentation skills; strong planning and organizational skills, leadership ability and proven talent for seeking and implementing solutions; methodical work approach; ability to work independently as well as in a collaborative, collegial, multidisciplinary environment.

Responsibilities:

  • Work within Quality & Compliance team to identify, define, maintain and improve companywide procedures ensuring a sound Quality Management System (QMS)
  • Assure process compliance with federal regulations, company procedural requirements and international privacy regulations
  • Interface with all levels of management to successfully manage and maintain Quality System documentation, departmental policies, best practices, and corrective & preventative action process
  • Inform management of any corporate non-compliance incidents or regulatory compliance issues, which may arise internally, or with customers, vendors, or contractors
  • Oversight of validation deliverables of Anju’s core applications and customer-specific developments; manage computer systems validation plans, validation reports and related documentation, responsibility of validation timelines of projects
  • Perform internal audits on staff/systems for adherence to SOPs/project specifications
  • Perform or coordinate external audits for Anju suppliers
  • Host client audits
  • Coordinate follow up actions resulting from audits and issue recommendations on areas requiring corrective action
  • Mentor Quality & Compliance staff

Skills Needed:

  • Demonstrated team and organizational leadership, development and support to direct reports and colleagues
  • Experience in developing and implementing processes and procedures
  • Acts firmly and responsibly to ensure all compliance and quality issues are noted and addressed, including analyzing findings and making recommendations for resolution
  • Ability to exercise sound judgment, organized and thorough approach to work
  • Excellent oral and written communication skills

Qualifications Needed:

  • 7+ years of industry experience in an FDA regulated or formal quality system environment
  • Background in computer control environments, experience with internal controls, risk assessments, QA operational auditing, change management
  • Certification/experience auditing Quality Systems preferred
  • Experience in the EDC process is preferred
  • Broad knowledge of relevant industry and government regulations including 21 CFR Part 11, Guidance for Industry: Computerized Systems Used in Clinical Investigations, and ICH GCP Guidelines and international privacy laws

Job Type: Full-time

Location: Ft Lauderdale, FL 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.