Manager Quality, Operations - Onsite - Marlborough, MA

Sartorius•Marlborough, MA

63d•Onsite

About The Position

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

Requirements

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

Nice To Haves

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

Responsibilities

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

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