- This role involves close collaboration with research and development, manufacturing, and regulatory teams to uphold and enhance quality standards.
- You will lead the implementation and maintenance of the Quality Management System (QMS) tailored to the biotechnology industry, ensuring compliance with regulatory standards such as FDA, EMA, and ICH guidelines.
- One of your tasks will be to drive continuous improvement initiatives within the QMS, including CAPA, change control, and risk management processes.
- You will ensure that all quality-related documentation is maintained in accordance with industry best practices and regulatory requirements.
- You will oversee the Document Control function to ensure that all critical documents, such as SOPs, batch records, and quality manuals, are controlled, accessible, and properly maintained.
- You will manage the lifecycle of documents, including creation, review, approval, distribution, and archiving, while ensuring version control and traceability.
- On an as needed basis, you will conduct periodic reviews and audits of the Document Control System to verify compliance and identify areas for improvement.
- In this role, you will develop and manage a robust Supplier Quality program, including the assessment and qualification of suppliers, vendors, and contract manufacturers.
- One of your duties will be to collaborate with suppliers to ensure the quality of raw materials, components, and services used in biotechnological processes.
- You will perform supplier audits and assessments, and work with suppliers to address non-conformances and drive quality improvements.
- Lead the development and execution of validation strategies for biotechnological processes, equipment, and cleaning procedures, ensuring adherence to industry-specific validation requirements.
- Oversee the preparation and execution of validation protocols (IQ, OQ, PQ) and ensure proper documentation of validation activities.
- Review and approve validation reports, ensuring that all validation activities are conducted in accordance with regulatory expectations and scientific principles.
- Provide leadership and guidance to the QA team, fostering a culture of quality and compliance.
- Develop team members through training, mentoring, and performance management.
- Facilitate cross-functional collaboration to proactively address quality issues and support the development and commercialization of biotechnological products.
- Maintain up-to-date knowledge of regulatory requirements specific to the biotechnology industry and ensure company-wide compliance.
- Lead preparation efforts for regulatory inspections and audits and manage responses to findings.
- Ensure that all quality-related activities are conducted in accordance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and other relevant standards.
- Establish and track key quality metrics to monitor the effectiveness of the quality system and identify areas for improvement.
- Generate and present quality reports to senior management, providing insights into quality trends, compliance risks, and process enhancements.
- You have completed a bachelor's degree Biology, Biochemistry, Biotechnology, or a related scientific field.
- Completion of master's degree or PHD in a Life Sciences discipline a plus.
- You have a minimum of 5+ years of experience in a quality assurance role within the biotechnology or pharmaceutical industry, with at least 1 years in a leadership capacity preferred.
- Comprehensive understanding of biotechnological processes and regulatory requirements.
- Demonstrated experience with Quality Systems, Document Control, Supplier Quality, and validation activities.
- Up to 10% travel domestic and international.
- Strong leadership skills with the ability to manage and develop a team.
- Excellent communication, analytical, and problem-solving skills.
- Professional certifications such as CQA, RAC, or similar are highly desirable.
- Ability to work in both office and laboratory/manufacturing environments.
- May require occasional lifting of laboratory materials and equipment.
- Identification with our core values: Sustainability, Openness, Enjoyment
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Quality Assurance Lead - Marlborough, United States - Sartorius AG
Description
As the Quality Assurance Lead, you will assume responsibility for supporting activities that are pivotal in ensuring the quality and compliance of our new emerging therapy services. This includes the new GMP Phase 1 clinical production facility in Marlborough MA with the focus on novel modalities including allogenic stem cell, cell and gene therapy, extracellular vesicles, and using next generation manufacturing methods.
Sartorius is one of the world's leading technology providers to the life sciences and biopharma industries, and is actively shaping dynamic, innovative and high-growth markets. To drive the creation of new innovative solutions, Sartorius has formed an initiative to discover new trends and cutting-edge opportunities for rapid conversion towards next generation technology solutions. This exciting initiative enables the research, development and clinical production of novel modalities using next generation manufacturing platforms, in partnership with key customers.
As the Quality Assurance Lead, you must possess a strong background in Quality Systems, Document Control, Supplier Quality, and Validation within the biotech industry. This business-critical function will support the continuity of the quality systems across the process development and clinical manufacturing.
What you will accomplish together with us:
Quality Systems Management:
Note: This job description is intended to provide an overview of the responsibilities and qualifications for the QA Lead position in the biotechnology sector. It is not exhaustive and may be subject to changes to meet the evolving needs of the company and regulatory landscape.
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, LinkedIn Learning, 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
All qualified applicants will be considered for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.
Please view equal employment opportunity posters provided by OFCCP here.
E-Verify Participation Info
E-Verify Workers Rights
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.
Sartorius is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
All employment decisions are based on valid job-related requirements.
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 calling ext 8330 or via e-mail at
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.
