Quality Systems Manager (On Site)

COMPANY OVERVIEW:

Sampled enables clients to advance human health by leveraging active biological samples through preservation, immortalization and utilization in comprehensive multiomics research within the only leading-edge Global Integrated Analytical Biorepository. 

To support the growth of the business, we are seeking an accomplished Quality Systems Manager with experience in Biotechnology, Pharmaceutical or Medical Devices to join the team based at Sampled’s Headquarters in Piscataway, New Jersey.  

Closing date for applications 26th August 2024

POSITION SUMMARY:

Reporting to the Director, Quality Assurance Operations, the Quality Systems Manager will be an advanced technical resource in the principles and application of quality systems and compliance. The role coordinates and executes alignment of procedures and processes related to the Quality Management System and helps drive Quality improvements. The job holder will coordinate projects and participate in the design and execution of processes. They will design, implement, maintain, and enhance Quality Systems company-wide. 

RESPONSIBILITIES:

• Manage QMS processes such as: Nonconformance/Quality Events, CAPAs, Complaints.
• Review and approve procedures in support of Sampled’s QMS. 
• Continually assess eQMS processes for potential gaps ensuring compliance with regulatory guidelines and industry standards.
• Responsible for the management of the eQMS including workflow configuration and upgrades as needed, collaborating cross-functionally to identify, define and implement process improvement opportunities for enhanced workflows. 
• Subject Matter Expert (SME) for the QMS, providing guidance and training on quality events, including but not limited to investigations, CAPAs, audit observations, etc. and driving the timely completion of records. 
• Support the creation and presentation of applicable QMS training materials to ensure on going education to core quality procedures and applicable industry standards
• Establish, compile, track, and present Quality Metrics to support Quality Management Review
• Participate in regulatory inspections and/or internal audits representing Quality System.
• Ensure that QEs/CAPAs resulting from audits associated with the assigned programs and studies are allocated an owner and closed out appropriately and timely.
• Write, review, or approve Standard Operating Procedures and internal investigations, as applicable.
• Proactively influence management regarding the implementation and/or adoption of standards to improve quality, efficiency, and compliance
• Strong leadership, communication, and cross-functional collaboration skills.
• Support internal and external inspections / audits as backroom Lead, encompassing identification, reporting and supporting process issues, working to offer solutions.
• Collaborate and communicate across operational areas of the business to ensure standardization of quality culture.
• Identify areas for continuous improvement in all areas of the business.
• Able to train and mentor other members of the Quality Assurance Team
• Able to deputize for the Sr. Manager, Quality Assurance as required
• Champion of the Sampled Values: Strive to delight our clients, move innovation forward, Accelerate your business, Rise together as a team, Transcend what is possible.
• Perform other tasks as assigned.

POSITION REQUIREMENTS:

• Ideally a Bachelor’s degree in Science or Engineering
• Relevant industry experience, ideally in Biotechnology, Pharmaceutical or Medical Device industry
• Extensive experience in Quality Assurance or similar regulatory field.  
• Extensive working knowledge of relevant regulations and standards; GLP, GCP, CLIA, ISO13485, ISO9001
• Strong understanding of Quality Management System principles and their application to drive continuous improvement.
• Excellent root cause analysis/CAPA, problem solving, and analytical skills.  
• Good communication skills, both verbal and written. Able to communicate effectively with clients, regulators, visitors, suppliers and colleagues.  
• Able to effectively lead and manage change and create buy-in to a Quality driven culture throughout the organization
• Good interpersonal skills, Acts professionally at all times. Easily builds rapport with others. Collaborative team member with those in Quality Assurance and all internal departments.  
• Results driven: Demonstrates the desire to achieve the best possible results. A self-starter, able to work with limited supervision.  
• Excellent analytical, problem solving and decision making skills.
• High level of accuracy and attention to detail.
• Strong planning, prioritization, project management and organization skills.  
• A desire to learn and progress within the business.

Sampled is committed to building a sustainable, inclusive and diverse culture where team members enjoy equal opportunities in a safe, supportive and empowering environment. Sampled believes that as an organisation we have a duty to be actively engaged in supporting not just the clients and industries we serve but the communities where we live and work.

Sampled is an Equal Opportunity / Affirmative Action Employer (M/F/Disabled/Veteran)