QA and Compliance Manager

What you will accomplish together with us

• Oversee and manage processes and quality approaches that support the development, documentation, and implementation of the Quality Management System at or beyond ISO Certification Requirements.
• Be the ISO Management Representative for the site
• Oversee and manage resolution and communication of quality issues between the Fremont Plant and customers
• Oversee Regulatory Compliance at the site in concert with Corporate SMEs
• Support Manufacturing Engineering in process validation, process control, process training and competency assurance programs, process improvement, risk management, and software validation and control
• Develop and/or review validation protocols, evaluate data, write and/or review reports
• Oversee and advise on new equipment IQ/OQ/PQs; ensure appropriate control points and proper settings and in place and validated
• Serve as resource for problem identification, improvement, and resolution
• Prepare reports that evaluate the effectiveness of quality systems; recommend improvements that strengthen our quality position
• Provide support for customer representatives regarding quality issues
• Work cooperatively in a team environment to reach common results and goals
• Work with suppliers to resolve or improve quality issues and to implement effective corrective action
• Develop and ensure maintenance of quality standards, requirements and deliverables for design and development projects
• Perform internal audits of QMS compliance
• Manage and coordinate customer complaint handling processes; ensure quick containment actions occur where required and rigorous investigations of root cause with corresponding countermeasures get implemented to prevent future occurrences
• Manage and coordinate internal non-conforming materials handling processes; ensure that root cause investigations of root causes and associated implementation of corrective and preventive measure are in place internally and at suppliers
• Manage and coordinate Quality metrics and KPIs reporting, trending and tracking against improvement targets
• Oversee the Management Review process and meetings
• Oversee auditing and monitoring of compliance to RoHS, REACH, Prop 65, CE Marking, WEEE, and other regulatory compliance requirements
• Other duties as required

What will convince us

• Bachelor's degree in Science, Engineering, or related field required
• 5+ years of experience managing a QA Team required
• Detail oriented with strong organizational skills
• Good problem-solving abilities using systemic, logical, and sequential approaches
• Knowledge of and experience with ISO requirements a must; GMP experience a plus
• Knowledge of and experience with instrument, reagent, and consumables products preferred
• Experience with compliance requirements including RoHS, REACH, CE Marking, and WEEE a plus.
• Identification with our core values: Sustainability, Openness, Enjoyment

Compensation for this position will be a base salary between $110,000.00 and $130,000.00 plus bonus depending on experience. (Higher starting salaries may be available in other locations based on geographic differentials.)

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