Career Opportunities

Director of Quality

Job Category:  Quality / Manufacturing

About Aldatu

Has SARS CoV-2 or monkeypox piqued your interest in biosecurity and pandemic preparedness? Do you have an interest in infectious disease and / or global health?

Through our innovative diagnostic platform, based on our proprietary qPCR-enabling technology, PANDAA, we are committed to providing access to infectious disease diagnostic that address longstanding challenges in global health, and which improve both the quality of patient care and healthcare cost-efficiency across the world.

Leaders in Adaptive PCR

Viral genetic diversity has been a major hurdle in the development of numerous diagnostic assays. One very prominent example is false negatives COVID-19 test results by SARS-CoV-2 variants.

Aldatu designed and implemented one of the first COVID-19 tests in New England, allowing major Boston hospitals to rapidly implement testing very early in the pandemic. Aldatu’s PANDAA qDx™ SARS-CoV-2 test—which is sold to clinical labs in a number of countries—leveraged the core features of our PANDAA technology to enable uniquely durable detection of SARS-CoV-2. Like our other diagnostics, this offers distinct longevity and utility for testing despite changes that may arise as viruses continues to evolve.

Our expanding R&D and product portfolios includes products for drug-resistant HIV, COVID-19 detection and variant genotyping, and viral hemorrhagic fevers.

The Person and Role​

We are seeking highly-motivated and talented individual to lead the manufacturing and regulatory strategy for Aldatu Biosciences’ PANDAA-based assays while ensuring adherence to Aldatu’s Quality Management System and GMP and ISO 13845 compliance. This position will oversee and support laboratory SOPs and documentation activities in collaboration with the cross-functional Aldatu Team to verify and validate product requirements and assay design in addition to leading the preparation of technical documents for CE-IVDR submission and qualification.­

To be successful in this role, you are expected to have a minimum of ten year’s hands-on experience in Quality Management Systems, be independently motivated, goal oriented, technically competent, and work effectively in a team environment. You should be willing to commit a minimum of two years as there are substantial growth opportunities within the company for the capable candidate.

What We Offer You

Hybrid Working
  • Starting at 20% remote and transitioning to up to 50% remote after six months. Note that this position is not fully remote.

Paid Time Off
  • Up to 30 days vacation each year: 18 days flexible paid time off in your first year, which is in addition to 6 federal holidays, 2 days over Thanksgiving, and a company holiday shutdown from 24th to 31st December [with flexibility if you need to observe a religious or cultural holiday at another time of year]

Benefits
  • Subsidized health, dental and vision insurance with several health insurance options such as HMOs and PPOs and includes cover for your spouse or domestic partner, children, and unmarried dependent children.
  • Participation in a 401(k) plan with company contributions.
  • Healthy Living Allowance of up to $500 per calendar year in reimbursement for costs incurred related to long-term activities that promote physical wellness.
  • Salary range of $125,000 to $140,000
  • Participation in a twice-yearly performance-related bonus scheme.

Primary Job Duties​

  • Design and maintain a fit-for-purpose quality management system (QMS) across the GxP’s. Take leadership of the refinement and expansion of Aldatu’s QMS to guarantee all procedures, training, and product records are compliant with SOPs and QMS regulatory standards throughout all stages of product development.
  • Supervise and train employees to guarantee all products are manufactured under compliance with ISO 13845 quality system standards, GMP procedures, and documentation is compliant with QSR design control.
  • Lead product manufacturing, kitting, shipping, and all order fulfillment activities to support product sales and clinical research activities.
  • Manage direct reports supporting manufacturing and product documentation in fulfillment of QMS design control while ensuring optimal documentation for each product.
  • Work collaboratively cross-functionally to establish and validate performance parameters, quality control and stability specifications across products platforms, and ensure that all procedures and documentation meets audits and are compliant with Aldatu’s QMS standards.
  • Work with the CSO/CEO to maximize Aldatu’s operational capabilities to guarantee product quality and performance to meet customer needs.
  • Interface with manufacturing partners (CMO), quality and regulatory consultants, notified bodies, and regulatory bodies and provide technical support to partners, collaborators, and customers. Ensure the qualification, selection and management of vendors and contractors through a defined qualified process.
  • Prepare and organize reports for both internal use (e.g., regular company meetings) and external use (e.g., NIH progress reports, grant applications, academic and/or industry partner communications, investor meetings, etc.)
  • Provide input to budget, forecast resource needs, and help to allocate expenditures efficiently for Quality-related activities and manufacturing processes.
  • Build and maintain the Technical Documentation Files and Design History Files for Aldatu’s products with the support and guidance of experienced regulatory consultants for CE-IVDR and other regulatory submissions.
  • Create and execute a plan for ensuring a state of inspection readiness and continuous improvement. Ensure company is inspection ready (FDA, Notified body, suppliers, or customers).
  • Create a process for identifying, adjudicating and remediating risks and/or compliance concerns/issues. Ensure rapid escalation of significant quality issues or concerns. Direct investigations and implement corrective actions.

Required Experience

  • BS. or M.S. with 10+ years of professional experience in successfully developing and implementing an ISO 13485-certified Quality Management System in the molecular diagnostics industry.
  • Experience overseeing product manufacturing, kitting, shipping, and other related order fulfillment activities in the diagnostics industry.
  • Interest in infectious disease and / or global health.
  • Ability to balance/prioritize research efforts across multiple programs, meet deadlines, and shift plans in service of a rapidly-changing startup environment
  • Exceptional communication, writing, organizational and time management skills, and attention to detail in recordkeeping.
  • Experience Using Microsoft Office products, including Word, Excel, and Teams

Preferred Experience

  • Ability to demonstrate having successfully developed and submitted technical files to stringent regulatory authorities for regulatory approvals (e.g., FDA or CE-IVD).
  • Experience successfully working closely with Notified Bodies while preparing for regulatory approvals.
  • Experience with acting as management representative for audits and inspections from clients and regulatory agencies.
  • Certification to audit third-party manufacturing partners are part of regulatory compliance.
  • Experience with real-time PCR setup, analysis using basic analytical QC methods, documentation of results, and reagent inventory management. Experience with QuantStudio real-time PCR platform is a plus.
  • Familiarity with working in start-up environment and / or with small teams.

Application Form

To apply, please fill out the online application form. Candidates should also upload a cover letter and CV (including publication list, if applicable) in the form prior to submission.

Aldatu is unable to sponsor employment-based visas at this time. Relocation assistance may be available for qualified candidates. No employment agencies, please.

Contact Name:

Larry Carrasco, VP of Operations

 

Salary Range:

$125,000 to $140,000

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