Director, QMS + Quality

We focus on categories where microbial innovations and microbiome-related products will disrupt and capture global market share in the coming years (e.g. oral care, skin care, infant health, etc.). We have built a strong foundation with breakthrough research and strong intellectual property, and believe there is a substantial opportunity to emerge as an innovative product line, backed by the most rigorous science.

We are building our best-in-class operations team to be both the mitochondrial engine of our rapidly expanding ecosystem, but also the cytoplasmic glue that keeps us all cohesively and efficiently connected -- working together to improve human and planetary health. You will report to, and support, our [Co-CEO/Co-Founder] in protecting our micro-organisms and ensuring that our customers enjoy an absolutely seamless experience across our current and future products. 

The Director , QMS + QC/QA is responsible for delivering an effective, efficient, and proactive Quality Management System to enable business success. The ideal candidate will be someone that can not only lead the company’s quality and compliance initiatives, but also isn’t afraid to roll up their sleeves and log data into our quality database as needed. Someone humble enough to enthusiastically tackle specific regulatory tasks one day and the next drive high-level strategic discussions and explain the nuances of quality requirements to all areas of the company. 

What You’ll Do

• Review and update the QMS: scope, policy, manual and procedures to assure compliance with ISO and regulatory requirements that drive continuous improvements as required.
• Support the implementation, configuration, and management of new electronic QMS and ERP software including document organization and migration.
• Monitor the completion and documentation of training across the different functions of the company. 
• Author quality processes for the company including but not limited to: training, change control, complaint management, and corrective action plans.
• Collaborate closely with Product Development and Legal in relation to US FDA regulatory matters (e.g. FSMA, FSVP, cGMP, cGLP), and regulatory matters in other jurisdictions (e.g. Health Canada, EFSA).
• Interface directly with both contract and third party analytical laboratories, in relation to testing protocols, specifications and adherence thereto, and assiduous monitoring and reporting of results.
• Plan, schedule and conduct internal and/or external (supplier, laboratory) quality system audits
• Cooperate with management personnel – particularly our operations and innovation teams—in formulating and establishing company policies, procedures, objectives and goals.
• Serve as the document / change control SME for the company and manage the completion of Change Requests for the cross-functional team including RD, Operations, Marketing and Finance.
• Develop a complaints management process and work with product quality to track device complaint investigations and failure analysis as required.
• Track compliance according to Q/A findings and educate the team.
• Develops and implements quality improvement plans defining standard scope of audit to mitigate future risk, and reports on research compliance activities.
• Support daily operations of internal quality systems including the full document lifecycle for Nonconformity Reports (NCRs), Corrective Actions/Preventive Actions (CAPA), version controls/release of updated component and device drawings, and Bill of Materials (BOMs).
• Develop a robust approach for statistical techniques to determine sample sizes for different types of products / testing.
• Support cross-functional meetings and activities as core team QMS Quality representative, as necessary.
• Monitor and report on relevant KPIs and metrics to assess the effectiveness of the QMS.

Who You Are

• Bachelor’s degree in a life sciences, healthcare, or technology discipline. Industry certifications, Master’s degree, or higher given preference, depending on experience. 
• 5+ years in a pharma and/or dietary supplements company. Ideally, one or more prior role(s) would include a clinical-stage company with ongoing clinical trials management.
• Experience within 1 or more QMS systems for 3+ years.
• Experience managing and/or working within a Complaints Management system, per ISO 13485:2016 and 21 CFR 820.111.
• Experience investigating, writing, and reviewing deviation and nonconformance reports, CAPA, and Change Requests.

The annual pay range for this full-time position is $160k-$200k + equity + benefits across all US locations (this position is 100% remote-US). Our pay ranges are guided by discipline, level and experience required. Within the range, individual pay may vary based on additional factors, including: your specific location, desired skills/ technical competency, relevant experience and advanced education/ training.

Benefits include: Medical, Dental, Vision, Life, AD&D, LTD, Mental Wellness, EAP, Wellness Stipend + 401(k) match.