Fullscript leads the way in proactive whole-person care, empowering over 100,000 healthcare practitioners to serve 10 million patients. Our platform enables practitioners to deliver complete care; designing holistic health plans, educating patients, managing lab diagnostics, and prescribing high-quality supplements—all in one place.
The Quality Systems Manager will oversee the electronic Quality Management System (eQMS), ensuring its configuration, implementation, and ongoing maintenance meet regulatory requirements. As the backbone of operational, quality, and compliance processes, the eQMS plays a critical role in supporting business operations and demonstrating regulatory adherence.
The Quality Systems Manager will partner with a diverse team of Quality, Regulatory, Operations, Merchandising and IT professionals, ensuring the effectiveness of our quality systems and processes while driving continuous improvement initiatives.
This role encompasses steering key QMS processes, managing non-conformance, implementing corrective and preventive measures, overseeing training, and ensuring document control coherence. Additionally, you will oversee electronic records, validation tasks, and bolster our overarching quality and regulatory efforts.
The position will also drive critical processes within the QMS; manage, drive, and provide metrics for the CAPA program, training, and document control. The Quality Systems Manager will also manage electronic records, validation activities, and support overall quality and regulatory initiatives.
What You'll Do:Responsible for the management, administration, implementation, maintenance and continual improvement of the Fullscript electronic Quality Management System. Manage the document control process and perform document control activities including creation, revision, approval, distribution, and storage across quality and operations to ensure documentation is complete, approved and archived in a manner that allows for efficient and effective recovery.Lead the effective implementation of CAPA practices and processes, providing metrics for the CAPA process and ensure timely and effective corrective and preventive actions are implemented.Oversee effective Quality Management System training by creating and implementing a training programProvide training to associates in ensuring effective CAPA investigations, root cause analysis and corrective / preventive actions. Develop a training matrix and drive the timely completion of cGMP and training requirements. Maintain and report on training metrics. Perform internal quality audits and / or product verification audits as needed to ensure compliance with regulatory requirements.Participate as a key team member in external audits (FDA, NSF, State, Customer) Ensure compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures.Perform verification and validation activities as needed and develop SOPs. Leads team members in enhancing their skills with quality processes, while nurturing a culture of excellence, responsibility, and ongoing advancement in quality. Guides quality and other team members to improve skill set with quality processes, and fostering a culture of quality excellence, accountability, and continuous improvement.Other duties as assignedWhat You Bring to the Table:10+ years of regulatory / quality assurance experience within a regulated industry e.g. food, dietary supplement, drug or medical device industries. Proven leadership experience in developing, implementing, and maintaining QMS processes.Expert working knowledge and experience in eQMS. ZenQMS experience preferred but not required. Proficiency in Google Suites and / or Microsoft office applicationsProven accuracy, reliability, and completeness in job executionWorking knowledge of regulations specifically relevant to Foods, Dietary Supplements, OTC, Medical Devices, and / or Cosmetic products.A thorough understanding of cGMP requirementsMeticulous attention to detail, superior organizational capabilities, and a keen investigative approach are crucialProactive self-starter with the ability to concentrate and drive tasks to completion autonomouslyExceptional verbal and written communication skillsWhy You'll Love Fullscript:Competitive Total Rewards offerings401(k) savings plan & matching (within US)Customizable Health BenefitsFlexible Paid Time Off programDiscounts on Fullscript catalog of products for self, family & friendsTraining allowance and company-wide learning initiativesWork Wherever You Work Well**Our Wherever You Work Well philosophy means Fullscript teammates get to pick their own office — whether that’s in-office, at home, or a bit of both 🐶🏡 For those not near a Fullscript office, remote work is supported within their home province or state, with occasional opportunities to connect in person.
Fullscript is committed to diversity in its workforce and is proud to be an equal opportunity employer. We are excited to work with talented people, period. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national or ethnic origin, gender, age, disability, sexual orientation, gender identity and/or expression, marital or civil status, political affiliation, family or parental status, or any other status protected by the laws or regulations in the jurisdictions in which we operate.
Accommodations are available on request for candidates taking part in all aspects of the selection process. Please send an email to accommodations@fullscript.com and let us know the nature of your request and your contact information.
Our team handles a lot of sensitive information, which means we require all candidates that receive and accept employment offers to complete a background check before being hired.
