Quality Assurance Supervisor

Company Description

With manufacturing sites across the US, UK, Germany and Denmark, LGC Biosearch Technologies has plans to continue growing. We deliver mission critical genomics to our diverse customer base in molecular diagnostics, pharma/biotech and agrigenomics. Our integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization.

Job Description

The Quality Assurance (QA) Supervisor will lead and manage the daily operations of a team of QA staff responsible for product design verification, validation, and transfer; documentation control for release of commercialized product; local quality management system (QMS) suitability; change and risk management; corrective and preventive actions; complaint resolution and root cause investigation; monitoring and reporting of relevant data and metrics. This role is expected to serve as the primary local QA business partner to teams within the Manufacturing, Supply Chain, EH&S, Commercial, Product Management, R&D, and Customer Service functions, among others.

In partnership with respective HR, operational leadership, and cross-functional stakeholders, this individual is expected to foster a positive work environment and a culture of ownership, continuous improvement, and accountability. This is a working management role expected to individually perform QA process duties and actions as required to meet business needs.

To perform this job successfully, an individual must be able to perform each of the following essential functions satisfactorily:

• Provide daily leadership to direct reports in the areas of safety, efficiency, quality control, cost, resources, and engagement in support of the organization’s commercial and operational activities
• Responsible for personnel activities of direct reports including business objective setting, staffing, resource planning, training, performance management, and staff development and effectiveness
• Ensure effectiveness of local quality management system (QMS), while also ensuring the highest standard of product quality and site compliance with applicable regulatory and customer requirements
• With support from direct manager, serve as Quality Management Representative for operational site under direct remit, including hosting third-party inspections and audits and chairing periodic management reviews of the QMS
• Regularly review, analyze, and report on key performance indicators (KPI’s) for team and functional area under direct remit
• In partnership with direct management, execute plans to improve the effectiveness of local QA procedures, processes, and business reporting
• Ensure effective delivery of, and timely resolutions resulting from, local QA operational processes; will directly participate in regular activities within these processes
• Serve as local business partner, with the relevant subject matter expertise, to local leaders and functional stakeholders
• Support deployment of global practices and platforms as directed by management
• Perform other duties as required to meet business needs

Qualifications

Minimum Qualifications:

• Bachelor’s degree in engineering, mathematics, business, life sciences—or equivalent combination of applicable education and relevant work experience
• Prior experience managing the quality assurance function, or a related product quality function, and delivery of associated operational processes within an ISO-certified manufacturing environment
• Proven behavioral and technical competency to effectively manage a team in a dynamic working environment
• Demonstrated experience performing risk analyses (e.g. FMEA, FTA, Risk Ranking/Filtering) and cross-functional root cause investigations throughout the product manufacturing lifecycle
• Working knowledge of an ISO quality standard such as ISO:9001 or ISO:13485
• Proficient computer skills, including working knowledge of Microsoft Office suite of products, particularly Word, Excel, and PowerPoint.

Preferred Qualifications:

• Prior experience in a medical device, biotechnology, or biopharma organization
• Prior experience in a GMP-certified manufacturing environment
• Proven success managing and developing business staff, with the demonstrated ability to effectively lead a team in a dynamic working environment
• Proven success directing and chairing large-group engagements, such as customer or supplier audits, ISO (re)certifications, and company management reviews
• Familiarity