The Product Quality Manager is responsible for providing quality leadership, oversight, and decision support throughout the product development lifecycle of bioprocess products and solutions. This role ensures that product designs, specifications, materials, manufacturing processes, verification and validation activities, quality control strategies, PPAP processes, production line qualifications, lifecycle testing plans, and technical documentation comply with applicable regulatory, customer, industry, certification, and internal quality requirements.
As the Quality representative within cross-functional development teams, the Product Quality Manager applies a risk-based approach to proactively identify and mitigate quality and compliance risks, challenge design and specification decisions when appropriate, and ensure that new and modified products are developed, validated, and launched in accordance with Sartorius Quality Management System (QMS) requirements and industry best practices.
Main Responsibilities & Tasks:
Product Development Quality Oversight
- Provide quality oversight throughout new product development, product modifications, and product lifecycle management activities for bioprocess products and solutions.
- Ensure quality requirements are integrated into product design, development, qualification, and commercialization processes.
- Participate in stage-gate reviews, design reviews, and development milestones to ensure compliance with applicable quality standards and requirements.
Design Quality & Compliance
- Review and approve design inputs and outputs, product specifications, material specifications, acceptance criteria, and technical documentation.
- Ensure compliance with customer requirements, regulatory expectations, industry standards, and internal quality requirements throughout the design and development process.
- Serve as the Quality representative in cross-functional project teams, providing independent quality assessment and guidance.
Risk Management & Quality Systems
- Apply risk-based quality principles and methodologies to identify, assess, and mitigate product, process, supplier, regulatory, and customer-related risks.
- Review and support risk assessments, design verification and validation activities, change controls, deviations, investigations, and CAPA processes.
- Ensure quality risks are appropriately documented, escalated, and resolved before product release.
Product Quality Assurance & Commercial Readiness
- Define and support the implementation of product quality control strategies, including Critical-to-Quality (CTQ) attributes, inspection plans, testing requirements, and release criteria.
- Support supplier qualification activities to ensure materials and components meet product quality requirements.
- Contribute to PPAP, manufacturing process validation, process qualification, and product transfer activities to ensure readiness for commercial production.
- Ensure product quality documentation and records are complete, accurate, and audit-ready.
Lifecycle Quality Management
- Support post-launch quality activities, including customer complaint investigations, root cause analysis, CAPA implementation, and continuous improvement initiatives.
- Monitor product quality performance throughout the product lifecycle and drive actions to maintain compliance, reliability, and customer satisfaction.
- Promote continuous improvement of product development quality processes, design control practices, and quality documentation standards.
Qualifications & Skills:
Qualifications and Experience
- Bachelor's degree in Engineering, Biotechnology, Life Sciences, Quality Management, or a related technical discipline; Master's degree preferred.
- Minimum of 7 years of experience in Product Quality, Design Quality, Quality Assurance, Quality Engineering, or Product Development within the life sciences industry.
- Experience in bioprocessing, biotechnology, pharmaceuticals, medical devices, or related regulated manufacturing environments is highly preferred.
- Proven experience supporting product development projects from concept through commercialization.
Knowledge and Skills
- Strong knowledge of Quality Management Systems (QMS) and product development processes.
- Solid understanding of applicable quality and regulatory requirements, including ISO 9001, GMP, GDP, and other relevant industry standards.
- Hands-on experience with design controls, risk management methodologies, design reviews, specification management, verification and validation, change control, deviations, nonconformances, investigations, and CAPA processes.
- Strong understanding of product lifecycle management (PLM) and technology transfer from development to manufacturing.
- Excellent analytical, problem-solving, communication, and stakeholder management skills.
- Ability to work effectively in a cross-functional and global matrix environment.
- Fluent in both written and spoken English.
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers