Position Summary:

The Senior Manager, Quality Assurance, Drug Product focus, will report to the Director, Quality Assurance. The Senior Manager is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Products and Devices meet regulatory requirements and internal Vera standards.

Responsibilities:

• Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements.
• Responsible for implementing strategies and tactics to promote and maintain GxP compliance.
• Lead quality aspects of and provide quality support on DP tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of commercial and clinical DP/ combination products.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc.
• Provides assistance during both internal and regulatory agency audits as required
  Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Lead for Quality Agreement with external partners.
• Support product lifecycle and continued process verification.
• Availability for 10-20% travel, both domestically and internationally.

Qualifications:

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred.
• Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
• Minimum 6+ years in a GMP QA role, with a preference for direct experience in biologics sterile DP manufacturing/aseptic processing including vials and prefilled syringes/autoinjectors.
• Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Innovative skills with problem solving and peer influence.
• In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
• Experience of working with external partners.
• Strong attention to detail is a must.
• Excellent interpersonal, written and oral communication skills.
• Outstanding organizational skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.
• Familiar with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is a plus.

 This role requires variant interpretation experience in a clinical or equivalent setting

About the Opportunity:

Full-time, US-based remote opportunity

At Genomenon, we are at the forefront of genomics research and innovation, with a mission to accelerate genetic discoveries and improve patient care.

We are seeking a Manager, Product Quality (Variant Interpretation) to lead the scientific rigor, consistency, and scalability of our variant interpretation efforts. This is a high-impact leadership role responsible for ensuring the accuracy and defensibility of data that powers our products, supports clinical decision-making, and informs pharmaceutical research.

As our curation volume, product complexity, and client engagements continue to grow, this role will serve as the scientific authority for complex variant interpretation while building and leading a high-performing QA function. You will shape how interpretation is done at scale—driving standards, improving systems, and mentoring a team of scientists.

If you are passionate about genomics, thrive in complex scientific problem-solving, and want to influence both product and patient impact, this is an opportunity to lead from the front.

Position Responsibilities:

Variant Interpretation & Scientific Leadership

• Serve as the final scientific authority for complex or ambiguous variant interpretation cases, including conflicting clinical and functional evidence
• Apply deep expertise in ACMG/AMP guidelines to ensure accurate and defensible classifications
• Leverage clinical experience to contextualize variant interpretations and ensure clinical relevance and applicability
• Guide evaluation of functional studies and literature to support high-confidence interpretation decisions
• Support high-impact client deliverables, including clinical and pharmaceutical use cases
• Germline experience preferred

Quality Assurance & Standards Ownership

• Own QA/QC standards across all variant interpretation workflows
• Ensure consistent application of internal frameworks, nomenclature standards (HGVS), and interpretation criteria
• Oversee external data quality, including ClinVar submissions and discrepancy resolution

Team Leadership & Development

• Manage, mentor, and develop a team of QA scientists and curators
• Provide coaching on interpretation, evidence evaluation, and best practices
• Set clear performance expectations and maintain accountability for quality standards

Process Improvement & Scalability

• Design, implement, and continuously improve SOPs, QA processes, and workflows
• Identify systemic quality issues and lead solutions that scale across teams and projects
• Balance standardization with flexibility to meet diverse client and product needs

Cross-Functional Collaboration

• Partner with product, engineering, and leadership to improve tools, workflows, and data quality
• Contribute to broader data and product strategy through scientific expertise 

About You:

You are a highly experienced variant interpretation expert who combines scientific depth with leadership capability. You’re comfortable making high-stakes decisions in ambiguous situations, and you take ownership of quality, not just your work, but the work of the team.

You bring a strong QA mindset, a bias toward evidence-based decision-making, and a drive to improve systems.

Required Skills & Experience

• 5+ years of hands-on variant interpretation experience in a clinical or equivalent setting
• Advanced degree (PhD, MS in Genetics/Genomics) or Genetic Counselor (CGC)
• Deep expertise applying ACMG/AMP guidelines in complex scenarios
• Strong experience evaluating clinical and functional evidence from scientific literature
• Proficiency in HGVS nomenclature, including normalization and variant disambiguation
• Demonstrated ability to make independent, high-confidence scientific decisions

Preferred / Nice to Have

• Experience with ClinVar submissions and resolving interpretation discrepancies
• Prior people management or strong leadership experience
• Experience developing SOPs
• Exposure to a broad range of disease areas or gene classes

What You’ll Bring

• Strong scientific judgment, especially in ambiguous or conflicting evidence scenarios
• A rigorous QA mindset with exceptional attention to detail
• Ability to mentor and elevate others
• Process-oriented thinking with a focus on scalability
• Clear, structured communication of complex scientific concepts
• Ownership mentality for quality, team performance, and outcomes

Why Join Genomenon

Own Scientific Quality at Scale
Shape how variant interpretation is performed across products, clients, and public data resources.

Lead and Build
Develop a high-performing team and establish systems that scale with the organization.

Make a Real Impact
Your work directly supports clinical decisions, patient outcomes, and pharmaceutical research.

Tackle Meaningful Complexity
Work on challenging, high-impact problems at the intersection of genomics, data, and real-world application.

Interview Process

• Initial Video Screen
• Technical Video Screen
• Take Home exercise
• Team Panels (2)
• TopGrading Interview

Are you a medical professional fluent in Arabic and eager to shape the future of AI? Large-scale language models are evolving from clever chatbots into powerful engines of scientific discovery. With high-quality training data, tomorrow’s AI can democratize world-class education, keep pace with cutting-edge research, and streamline clinical work for healthcare professionals everywhere. That training data begins with you—we need your expertise to help power the next generation of AI.

We’re looking for Arabic-fluent professionals with a strong medical background—whether you’ve worked in clinical care, medical research, public health, biomedical education, or related fields. You should be comfortable engaging with topics across medicine, including internal medicine, pharmacology, pathology, clinical diagnostics, medical ethics, human physiology, epidemiology, immunology, and evidence-based medicine. You’ll challenge advanced language models on subjects like differential diagnosis, drug interactions, treatment protocols, pathophysiological mechanisms, clinical trial design, public health interventions, and diagnostic imaging interpretation—documenting every failure mode so we can strengthen model reasoning.

On a typical day, you will converse with the model on clinical scenarios and theoretical medical questions in both Arabic and English, verify factual accuracy and logical soundness, capture reproducible error traces, and suggest improvements to our prompt engineering and evaluation metrics.

A background in medicine, healthcare, or biomedical sciences is required. This could include clinical experience, academic or research work, health communications, medical translation, or public health engagement. Clear, metacognitive communication—explicitly articulating reasoning and decision processes (“showing your work”)—is essential.

Ready to turn your Arabic medical expertise into the knowledge base for tomorrow’s AI? Apply today and start teaching the model that will teach the world.

We offer a pay range of $6 to $65 per hour, with the exact rate determined after evaluating your experience, expertise, and geographic location. Final offer amounts may vary from the pay range listed above. As a contractor, you’ll supply a secure computer and high-speed internet; company-sponsored benefits such as health insurance and PTO do not apply.

Job title: Medical Specialist (Fluent in Arabic) – AI Trainer
Employment type: Contract
Workplace type: Remote
Seniority level: Open