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Sartorius Manager of Quality - Marlborough in United States

Sartorius is seeking an experienced leader for the unique opportunity to lead the Quality Organization of the Emerging Therapies Group. The ideal candidate will bring significant experience in building Quality enterprise for advanced therapies including direct experience in managing internal GMP operations for early clinical stage drug product manufacturing.

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 and emerging therapies using next generation manufacturing platforms, in partnership with key customers.

What you will accomplish together with us:

  • In this role, you will establish and lead quality operations by establishing a clear roadmap for the establishment of the Quality Organization

  • You will implement and administer an effective Quality Management System in adherence to regulatory guidelines and best industry practices for advance therapy products and biologics.

  • One of your tasks, will be to partner across the organization to understand Quality practices across geographies and align with Sartorius’ global GXP organization.

  • You will lead quality oversight for all GXP activities internally and externally ensuring systems and processes are in-place and in-use for compliance with global current good manufacturing practices (cGMP).

  • On an as needed basis, you will ensure audit readiness for multiple regulatory agencies including the USFDA and EMEA

  • Implementing Quality by Design (QBD) from the early development stages by defining product quality and regulatory profile.

  • You will provide active leadership to the Quality Organization by flagging critical risks and implementing solutions early.

  • On a regular basis, you will provide Quality oversight of all relevant contracts, including Quality agreements, to meet the quality and regulatory requirements for both Sartorius and regulatory agencies.

  • Develop and maintain Risk Management plan.

  • You will provide quality guidance and training to the broader team.

  • Perform quality audits of sub-contractors and vendors.

  • You will recruit and manage direct reports in the Quality Organization.

What will convince us:

  • You have completed a Bachelor’s degree in biology, life sciences or a related field.

  • Master's degree in Science or PhD in Engineering or biotechnology preferred.

  • You possess a minimum 5+ years QA experience in biotech or pharmaceutical fields.

  • You possess a minimum 5+ years’ experience in Technical Quality functions with a successful experience as a manager - industries targeted biotech, pharma, API/Excipients manufacturing or culture media.

  • Deep understanding of global regulatory landscape for biologics and advanced therapy manufacturing.

  • Should have proven ability and experience in establishing QMS systems.

  • Experience in managing Quality System for an internal cGMP manufacturing facility.

  • Strong knowledge of GMP, Medical device & industry standards (21 CFRs/ ISO13485/ ICH Qs).

  • You are able to travel (domestic and international) up to 15% as well as work on weekends when needed.

We Value:

  • Strong leadership skills

  • You have the ability to effectively plan and manage projects.

  • Exceptional problem-solving skills and demonstrated ability to proactively identify and resolve product & project related risks.

  • Excellent communication skills both written and verbal with fluency in English with the ability to understand multicultural differences in regions and can develop and deliver influential presentations to a wide audience.

  • 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, 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 (https://www.dol.gov/agencies/ofccp/posters) .

E-Verify Participation Info (https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf)

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.

www.sartorius.com/career

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 +1 631 254 4249 ext 8330 or via e-mail at accommodationrequest@sartorius.com

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

to our Candidate Portal and thank you for your interest in working and growing with us. We look forward to receiving your application. You can check the status anytime in this portal.

Here you will find the best application tips from our HR team.

Information on the application process can also be found in this video and under FAQ & Contact (https://www.sartorius.com/en/company/careers/faq) .

In this brochure (https://www.sartorius.com/resource/static/celum/202114/23_EN_Candidate_Booklet_Digital_web.pdf) you will learn more about us as an employer and your career with us. For further insights, please visit the Sartorius Blog (http://www.sartorius.com/en/company/newsroom/blog) and our career website (http://www.sartorius.com/en/company/careers) .

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