Junior Quality Manager
The Junior Quality Manager coordinates documentation workflow to ensure that project work is conducted in compliance with the Quality Management System (QMS). The Junior Quality Manager is also responsible for routing and general quality control of project and software validation documents, ensuring that all processes are current, effective, and trained in compliance with regulatory expectations.
The position requires a high level of organization and integrity as this person is working on various collaborative projects and preparing documents that may be submitted to regulatory agencies (such as FDA, EMA, TGA) as needed, and whose actions impact the quality and reliability of these projects. This position comes with the potential for further career development.
Objectives of the Role
We are looking for a detail-oriented candidate with stellar communication skills to join our QA team. The ideal candidate will be responsible for maintaining and improving our quality system and imparting a “culture of quality” to support the scale up of our organizational capabilities in software development and related services. This individual will also operate as local regulatory subject matter expert and play an essential role in success of our business by ensuring compliance adherence.
- Interpret, build upon, and comply with company quality assurance standards.
- Carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions.
- Document quality assurance activities with internal reporting and audits.
- Identify training needs and take action to ensure company-wide compliance.
- Pursue continuing education on new solutions, technology, and skills.
- Support compliance with regards to GxP, SOPs, EU directives, regulatory agencies and national/local guidelines.
- Provide document coordination support for company staff.
- Review of company QMS Documents.
- Review and approval of validation documents for adequacy and adherence to SOPs.
- Collaborate with other departments to ensure validation activities are executed in a compliant manner.
- Provide support for other compliance- and validation-related initiatives.
- Create and maintain staff training documentation and records.
- Assist in the development and presentation of training material.
- Assist with controlling QMS and project-related documentation and records, including monitoring, tracking, and reporting overdue items.
- Support planning, executing, and reporting internal and external audits.
- Coordinate and assist in audits and audit support.
- Coordinate project planning, execution, monitoring, and reporting.
- Other project work and responsibilities as required.
Qualifications and Education Requirements
- Bachelor’s degree or commensurate experience.
- Proficient verbal/written communication and interpersonal skills including the ability to deliver information effectively and facilitate team processes in person and via telephone or e-mail.
- High degree of self-motivation and attention to detail.
- At least 1 year of hands-on Quality Management, Document Control, or Start-Up experience preferred.
- Basic knowledge of computer system validation principles, quality systems, software engineering design fundamentals, regulatory expectations, and industry trends.
- Ability to work collaboratively and take direction from multiple inputs.
- Ability to manage and meet multiple deadlines and respond to multiple requests for support.
- Ability to quickly learn and apply new skills, procedures, and approaches.
- Ability to work in a team-oriented environment, providing back-up support to team members and establishing/maintaining effective work relationships with co-workers within and across functional areas.
Pumas-AI is a young company led by decades of experience in diverse areas of healthcare and mathematical modeling. With a focused goal on providing better solutions for patient care, be it via pharmaceutical drug development innovation or tools for point of care, Pumas-AI aims to bring value, innovation, and efficiency to healthcare. We build technology that converts the power of science into real-world applications with unprecedented speed and accuracy. At the core of everything we do is our commitment to move science forward.
We are a virtual company with team members in several countries. While this means we can work remotely from anywhere, it also means we've developed a unique culture that thrives on transparency, communication, and creativity. Each of us respects the commitments we have outside of work – and the trust and flexibility to attend to them, encouraging a healthy work/life balance.
Pumas-AI is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Our culture is one that encourages, supports, and celebrates our diversity and looks to bring out the best in each other.
Do the work you love and make an impact in the lives of millions. Join us!
Terms of Employment
Reports to: Operations
Travel Required: None
Position Type: Full-Time
Multiple openings available. Please send cover letter and CV to firstname.lastname@example.org.