Manager of Quality

As the Manager of Quality, you will create the quality packages for each customer project according to regulatory requirements, customers need and the department QMS. The scope will be to drive quality objectives for Process Development and clinical production of novel biological modalities such as cell & gene therapy, extracellular vesicles, and lipid nanoparticles with nucleotide cargos. The manufacturing of drug substance and drug product will use next generation bioprocessing platforms including continuous and integrated production for mAbs and viruses.

What you will accomplish together with us

• Implementing and monitoring the Quality Management System adhere to regulatory strategies for compliance with established standards and agency guidelines for ATMPs/HTCs.
• Monitoring and supporting product and service conformity.
• Implementing Quality by Design (QBD) from the early development stages by defining product quality and regulatory profile.
• Developing and implementing quality systems, procedures, and initiatives to achieve compliance with regulatory requirements provided by RA department.
• Overseeing quality management policies, processes, procedures, and controls thus ensuring performance and quality of the products and services confirms to established standards and regulatory guidelines.
• Providing leadership for quality systems improvements.
• Generating quality package as part of the process development service
• Developing documents used in good manufacturing practices monitoring audits of quality control areas.
• Develop and maintain Risk Management plan.
• Providing QA guidance and training to the department team.
• Qualifying sub-contractors and vendors.
• Collaboration with PD, PM and RA to deliver the best process development package
• Furnishing and approval of quality agreements with customer, vendors, and sub-contractors.
• Managing direct reports.

What will convince us

• Bachelor’s degree in biological, life sciences or related field
• Master's degree in Science or PhD in Engineering, biotechnology, or related field preferred
• 5+ years’ QA experience in biotech or pharmaceutical fields.
• 5+ years of experience in Technical Quality functions with a successful experience as a manager - industries targeted biotech, pharma, API/Excipient’s manufacturing, or culture media

Additional Skills:

• Experience in ISO or cGMP systems.
• Strong knowledge of GMP, Medical device & industry standards (21 CFRs/ ISO13485/ ICH Qs)
• Planning and project management skills.
• Problem-solving ability
• Excellent communication skills
• Strong leadership skills
• Collaborative team player
• Experience in remote management
• Experience in international working environment
• Identification with our core values: Sustainability, Openness, Enjoyment

What we offer

Sartorius’ ambition is to simplify progress in the bio-pharmaceutical industry to help translate scientific findings into new therapeutics faster and more efficiently. Nearly 16,000 employees at more than 60 sites are working together on achieving our goal: Better health for more people. And together, we have grown strongly over the past years. Enjoy the advantages of working with a global player:

• Opportunity for international career development:
  a global network offering seminars and training sessions, expert and manager career paths
• Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration
• Work-life balance: Working from home at many sites
• Intelligent working environment: working in smart buildings with the latest technology and equipment
• Ambitious goals: Sartorius plans to double its sales revenue approximately every five years
• We offer a comprehensive array of benefits which include: Paid Vacation (3 weeks), 7 sick days (eligible to carry over up to 30 days), 11 Corporate Holidays, 2 Floating Holidays, Community Service Day, Medical, Dental, Vision, Company Paid and Supplemental Life Insurance, STD & LTD, 401k (with generous company match), Tuition Assistance, Flexible Spending Accounts, Employee Assistance Program, Health and Wellness Program (in addition to other benefits).

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.

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We look forward to receiving your application.

www.sartorius.com/career