Manager Quality, Operations - Onsite - Marlborough, MA

Sartorius is seeking a Manager, Quality Operations, to join our team in delivering high-quality products to customers worldwide.
As the Manager, Quality Operations, you will play a key role in upholding product quality standards and collaborating across departments to ensure operational excellence.  In this role, you will oversee manufacturing quality operations and ensure our quality systems are effective, compliant with regulatory standards, and aligned with customer expectations. You will also lead continuous improvement initiatives within the facility to drive performance and support sustainable business growth.

This is an on-site position in our Marlborough, MA office.

What you will accomplish together with us:

• Provide direct, hands-on leadership for quality operations, including shop floor presence and real-time problem solving, while evaluating processes and policies for improvements on speed and output
• Oversee the team responsible for quality control testing, inspection processes, and release of manufactured products
• Lead manufacturing quality investigations and implement effective corrective actions
• Connect cross-functional teams, set expectations, and remove barriers to expedite customer response/closure
• Lead strategic improvement initiatives to advance site-wide quality standards
• Manage team focused on incoming inspection, in-process controls, and final product release processes, establishing improvements based on experience
• Coach and mentor team to build technical expertise and drive accountability
• Develop and implement practical quality control methods for production environments
• Prepare for and host ISO and customer audits focusing on manufacturing areas and cross-functional site quality influences
• Drive operational quality metrics, trending, and continuous improvement initiatives
• Ensure proper validation of manufacturing processes, equipment, and test methods
• Collaborate closely with Production, Engineering, and Supply Chain to resolve quality issues
• Implement effective nonconformance management and material review processes
• Ensure manufacturing personnel are appropriately trained in quality requirements
• Oversee and maintain Corrective and Preventive Action (CAPA) Program. Ensure all quality events are documented, investigated, assessed for impact, root cause, and risk, and all associated actions are completed on time
• Ensure all Risk Management activities are executed and maintained according to all regulatory standards
• Represent Quality for new and existing product development/manufacturing transfers and quality plan initiatives
• Manage Quality Management Review
• Actively participate in Operations and other business review meetings
• Ensure the effectiveness of QMS training program
• Lead internal audits
• Monitors audits of production and Quality Control areas
• Work cross-functionally with other departments
• Willing and able to travel up to 10%, including international travel

Basic Qualifications:

• Bachelor’s degree in Quality, Engineering or in a related field
• 7+ years of quality experience
• 3+ years of management experience
• Strong understanding of Quality Management Systems (QMS), with hands-on experience implementing and executing processes in compliance with ISO 9001 standards.
• Proficient in applying 5S principles to maintain lab organization, improve efficiency, and ensure a safe working environment.
• Expertise in risk management, complaint investigation, root cause investigation, corrective/preventive action, and data analytics practices, tools and principles, and systemic issue resolution

We Value:

• Experience working in a manufacturing and/or production environment
• Experience establishing operational objectives and work plans
• Experience establishing and assuring adherence to budgets, schedules, workplans, and performance requirements
• Advanced understanding of GMP requirements, regulatory compliance, and validation procedures in biotech/pharma settings
• Familiarity with managing laboratory processes and/or clean rooms, including implementing 5S principles
• Expertise in developing and improving processes to maintain compliance, audit readiness, and efficiency
• Experience developing long-term strategic goals
• Excellent written, verbal, and interpersonal communication skills to foster a solutions-oriented team culture
• Strong organizational and documentation skills with an emphasis on data-driven decision-making
• Recognized certifications such as ASQ Certified Quality Engineer (CQE)

• Identification with our core values: Sustainability, Openness, Enjoyment

What We Offer

As a growing global life science company, with our stock listed on the German DAX and TecDAX , Sartorius offers a wide range of benefits:
Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings
Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.

Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate
Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability or based on status in any other protected group of class.

Please view equal employment opportunity posters provided by OFCCP here.

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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.

We look forward to receiving your application.

www.sartorius.com/career

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at [email protected]

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability, or based on status in any other protected group of class.

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at [email protected]

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