Quality Manager

ABOUT SANISURE

SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines.

We continue to be on a robust growth trajectory, via both organic and inorganic growth, as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.

Our primary offering includes high-value assembly solutions and a portfolio of market-leading products, including PharmaTainer bottles and carboys and related assemblies, Mixed4Sure mixing solutions, Flex4Sure bags and bag assemblies, Fill4Sure needles and needle assemblies, fittings, clamps and a wide range of silicone, braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fast-growth applications, such as cell and gene therapies.

SaniSure is a high-growth, nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure!

Summary

The Quality Manager is responsible for overall development, implementation, and maintenance of the organization’s ISO 9001:2015 program, Quality Management System (QMS), Quality Control and Quality Assurance business areas.

Essential Duties and Responsibilities

• Manage organization’s QMS and ensure the program conforms to customer, internal, and compliance requirements. Includes management of internal/customer audits and support for customer technical visits.
• Responsible for all quality concerns as they relate to sales and customer expectations. This includes investigating, reporting and trending customer product complaints and compliance related non-conformances.
• Provides technical assistance and direction to the other functional groups. Interfaces with regulatory agencies in conjunction with new device submissions and during routine audits, field complaint investigations and technical interchanges to present the company's viewpoint.
• Interact and support to Sales team regarding customer product inquiries (data packages), and other technical quality related areas.
• Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality and systems consistent with department and company operating objectives.
• Employ hiring practices which focus on key skills and talent that supports department and company objectives. Ensure development and training plans are established for all staff.
• Provide clear and routine feedback on progress and guidance throughout our employees' developmental process.
• Oversees the investigation of excursions in manufacturing or other related operations resulting in operation rejections. Resolves nature of cause, impact, disposition, and corrective action.
• Ensure investigations resulting from nonconformances, product incident reports or excursions, technical documentation of investigation results, and preparation of correspondences to regulatory authorities are effectively managed.
• Review product, processes, and material related nonconformances for technical accuracy, completeness, and justifications supporting recommended actions to be taken.
• Develop and maintain Quality Control (QC) processes ensuring effective inspection and compliance of incoming materials and manufactured assemblies.
• Effectively manage Supplier Management program ensuring key suppliers are evaluated through risk assessment, audited, and are following our company requirements.
• Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions, testing analysis, KPIs), including the need for improvement. Conduct quarterly management review meetings.
• Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products.
• Ability to lead and develop a vision and strategy for process improvement through lean/six sigma, validation, and process improvement initiatives to advance our quality programs and meet the needs of our global customers.
• Responsible for driving effective organization containment and corrective action processes to support product or quality system failures.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Experience in Quality Management System (ISO 9001:2015).
• Knowledge of cGMPs, medical or pharmaceutical products.
• Familiarity with requirements for submissions to regulatory agencies.
• Strong knowledge of CAPA.
• Experience in interfacing with FDA and notified bodies during audits.
• Experience implementing ISO 9001 or 13485.
• Experience in writing audit responses.
• Solid knowledge of risk management, validations, design controls, process development, monitoring, statistical controls, and root cause analysis.
• Experience with the management of outsourcing and vendor management.
• Capable of applying statistical and process improvement techniques to operational issues of significant scope and complexity.
• Must have product release, containment and recalls experience.
• Excellent written and verbal communications skills required.
• Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside the company.
• Ability to manage multiple priorities and tasks in a dynamic environment with attention to detail.

Supervisory Responsibilities

Supervises quality department employees in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; addressing disciplinary actions, and resolving problems.

Education and/or Experience

• Bachelor's (BS or BA) in the Life Sciences, Business Management, or related discipline.
• 8+ years professional experience with documentation and implementation of quality management systems, product inspection/testing
• Demonstrated success in Root Cause analysis and correction action

Certificates, Licenses, Registrations

Quality certifications desired: American Society for Quality Auditor, Engineer or Manager; Lean Practitioner, Six Sigma Green/Black Belt, or equivalent experience.