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 management and continuous improvement of Plant Quality Systems including customer and internal corrective/preventive actions and effectiveness, customer specification management, internal audit, and testing and inspection processes. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and process improvement. Provides training and leadership for all team members including development and professional growth.

Essential Duties and Responsibilities

• Ensure that facilities, equipment, materials, organization, processes, procedures and products align with ISO 9001 & 13485 and applicable standards.
• Lead the quality assurance processes across different regions and product lines, ensuring product meet quality standards
• Provide oversight to disposition of high-risk product nonconformances, assure adequate technical investigations and appropriate corrective actions are in place to prevent reoccurrence
• Develop, implement, and maintain quality management systems and policies.
• Support internal audits and certification audits at SaniSure and its suppliers
• Provide leadership to the Quality team to proactively identify quality signals and trends and drives actions needed to mitigate adverse quality trends
• Train and mentor personnel on quality control processes and best practices.
• Ensure appropriate staff development and training in areas of responsibility
• Ensure documentation of quality processes follow industry standards.
• Stay updated on industry regulations and changes in quality standards.
• Set and track department goals and objectives in alignment with company goals.
• Identify areas for cost reduction and increased efficiency.
• Address employee concerns and resolve conflicts, coordinate with Human Resources as needed.
• Collaborate cross functionally and across the SaniSure Organization to ensure the Quality Management System processes are implemented, maintained and performed in accordance with established procedures and applicable standards.
• Champion, maintain, and support continuous improvement to the product QMS, monitor and identify areas for improvement and ensure remediation
• Support development and management of Quality Agreements, external audits of suppliers, and third parties with Supply Chain
• Ensure team members adhere to company policies and procedures including PPE and ISO regulations.
• Approve timekeeping records in timekeeping system.
• Perform other duties as assigned.

Education and/or Experience

• Bachelor’s degree in Quality Management, Engineering, or a related field; Master’s preferred.
• 5 years of experience in quality management or a similar role.
• Strong knowledge of quality assurance methodologies (e.g., Six Sigma, ISO 9001, ISO 13485).
• Excellent analytical and problem-solving skills.
• Strong communication and leadership abilities.
• Proficient in quality management software and tools.
• Certification in Quality Management (e.g., CQE, CQM).
• Skilled professional able to lead and motivate a team, manage performance and resolve conflicts.
• Excellent verbal and written communication skills.
• Able to manage multiple priorities and meet deadlines.
• Competent in interpreting data, generating reports and making data-driven decisions.
• Proactive approach to identifying opportunities for improvement and driving positive change.

Certificates, Licenses, Registrations

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

SaniSure is an Equal Employment Opportunity Employer.

SaniSure does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at humanresources@sanisure.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.