This is a fully Remote and Work From Home (WFH) opportunity within the US

Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. The Science 37 Operating System (OS) enables universal access to patients and providers, leading to faster enrollment, greater retention and a more representative patient population. To help us achieve our goal, we are seeking a Quality Assurance Manager eager to make an impact within a mission-driven organization. 

The QA Manager-QMS is a generalist role that will support the Quality Management System within Science 37. The areas of focus include: Documentation, Deviations, CAPAs, Client Audits, Internal Audits, Quality Management Review, and other quality initiatives. This role will help ensure QMS items are created, processed and completed in a timely fashion.

The Quality Assurance Manager - QMS is a hands-on role that will interact with all regulatory functions within the company.

DUTIES AND RESPONSIBILITIES 

Duties include but are not limited to: 

1. Developing, reviewing and approving SOPs and other controlled documents
2. Supporting the timely periodic review of Controlled Documents
3. Participating in internal audits of Science 37 operations
4. Supporting Deviation and CAPA investigations and resolution. 
5. Participating in client audit preparation, hosting and follow-up.
6. Ensuring client audit findings are documented, assigned and resolved within defined timeframes.
7. Assisting with the administration of the electronic Quality Management System
8. Remaining abreast of current regulations and industry best practices in clinical trials.
9. Participating in other Quality Organization projects and initiatives as required

QUALIFICATIONS & SKILLS 

Minimum Qualifications:

The following qualifications are preferred and/or equivalent applicable experience:

1. Bachelor’s Degree in science, engineering or other related field required
2. 5 years of experience in clinical research, biotechnology or other GxP environment specializing in Quality Assurance/QMS
3. Proven track record of cross functional collaboration
4. Excellent written and oral communication skills
5. Ability to meet deadlines in a fast-paced environment

Preferred Qualifications 

1. ASQ CQA certification

Skills/Competencies

1. Familiarization with QMS systems (i.e., Veeva, ZensQMS, Trackwise, etc.)
2. Knowledge of cGXP regulations and current industry best practices 
3. Excellent interpersonal skills and savvy – Understands interpersonal and group dynamics and reacts in an effective and tactful manner. 
4. Strong organizational skills – ability to adapt to a rapidly changing work environment and remain in control of various project and changing priorities.
5. Ability to provide guidance and structure while encouraging innovation.

Capabilities

1. Ability to communicate in English (both verbal and written)

REPORTING 

The incumbent reports to the Director of QMS who will also assign projects, provide general direction and guidance. Incumbent is expected to perform duties and responsibilities with minimal supervision. 

DIRECT REPORTS 

No direct reports 

Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

Submit your resume to apply!