Director of Biorepository Operations

About GenVault

GenVault is a premier provider of bioinventory storage and lab transport solutions. Our state-of-the-art biorepository facility is expertly designed for unmatched security and preservation of critical biological samples and materials. Through reliable and customized solutions, we offer peace of mind to our customers that their invaluable resources are expertly protected.

Job Summary:

The GenVault Director of Biorepository Operations will function as a leader, innovator, coordinator, and change agent in the pursuit of improved operations, and is accountable for managing (planning, organizing, staffing, influencing, and controlling) all components of the Biorepository. 

Job Description:

As the Director of Biorepository Operations, you will manage the onsite team(s) while implementing the day-to-day strategic activities associated with sample management, compliance, quality, logistics and training.  This position is responsible for creating, designing, and implementing systems, processes and policies while maintaining the mission and core values of GenVault.  This role is responsible for ensuring compliance with all relevant policies, procedures, guidelines, and all other regulatory and accreditation standards.

Responsibilities:

• Drives a strong quality culture by ensuring policies, procedures and work instructions prioritize safety, and ensures that appropriate monitoring and reporting processes are in place and effective.
• Coordinate and approve client projects as related to sample transfer and storage of regulated material.
• Ensure compliance issues/concerns within the platform are appropriately evaluated, investigated and resolved using online QMS software.
• Establishes programs to monitor and control costs in relation to volume and pre-established targets.
• Reconciles statistics and adheres to revenue management standards.
• Maintains productivity standards; organizes and manages staff variable in relation to volume, service, and financial goals.
• Implement new policies and procedures for new compliance requirements and support evolving operations towards continual improvement.
• Assist with client inventory organization projects, remote or on-site including sample consolidation, freezer cleanout and process improvement of client sample management systems.
• Assist with the investigation, auditing, review and analysis of general compliance, HIPAA privacy, ensure compliance with governmental regulations and internal policies.
• Identify areas for audit opportunities based on industry performance, regulatory focus areas and risk areas within the organization.
• Supports QA function in preparing for, hosting and providing follow up for client and regulatory audits.
• Coordinate educational and training programs that focus on compliance programs to help ensure all employees understand applicable regulatory guidelines and company policies.
• Assist in authoring IQ/OQ/PQ UAT Scripts.
• System manager for validated computer and equipment systems, working closely with Executive Director to manage validation and change control activities.
• Assist with observing cloud-based monitoring system for environmental condition.                                        

Education and Experience:

• Four-year degree in the field of science
• 4+ years related management experience 

Preferred:

• 4 year degree in the field of life science
• FDA, CLIA, ISO, GMP experience
• Proficient in using biorepository management software/quality management software and other relevant software applications
• Supply chain management and procurement experience
• Strong business acumen and analytical skills
• Excellent leadership skills and ability to work across organization
• Strong communication and interpersonal skills
• Experience in customer service-oriented positions
• Proven ability to work effectively with teams

Job Type: Full-Time/Some Travel  <10%

Work Location: West Deptford, NJ

Salary: $100k – $150k

Total Rewards:  

·         Health/Medical Benefits

·         Health Reimbursement Account

·         Flexible Spending Account

·         Dental, Vision, etc.

·         Company Paid Short-Term Disability

·         Company Paid Long-Term Disability

·         Accident/Critical Illness/Hospital Insurance

·         Pet Insurance Options

·         PTO

·         401K with Employer Match

 Physical Requirements:

• Reaching, lifting, bending
• Ability to lift 50 lbs.
• Extended periods of standing or sitting
• Right- and left-hand finger dexterity
• Ability to discern colors or use of color correction glasses
• Ability to work with refrigerants (e.g., dry ice and LNs) using proper PPE

Environmental Exposure:

• Category I: Jobs requiring tasks that involve exposure to human blood or other potentially infectious materials

We are an equal opportunity employer and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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