Quality Lead - Pharma Equipment

• Start strong – Medical, dental, and vision coverage begins on your first day

• Recharge and refresh – Enjoy 12 paid holidays, including a flexible floating holiday, and 136 hours of PTO to relax or explore

• Invest in your future – A 7% 401(k) employer match helps grow your retirement savings faster

• Keep learning – Take advantage of tuition reimbursement to further your education or skillset

• Live well – Our wellness incentive program rewards healthy habits

• Get support when you need it – Access to a confidential Employee Assistance Program for personal or professional guidance

• Save smart – Flexible Health Savings and Spending Accounts to manage out-of-pocket expenses

GEA Group in Columbia, MD is searching for a newly created Quality Manager to lead all quality functions for the Pharma Team in our Food and Healthcare Division. This is an exciting opportunity for someone who is looking to build a Quality program from the ground up, develop local suppliers, and work with other Quality individuals at customers and suppliers all over the nation!

Responsibilities:

• Create and monitor a quality program (Quality Management System) for Pharma and Food Solutions NAM.

• Coordinate adequately with existing management systems and certifications

• Introduce adequate systems to monitor the performance of the Quality management system, produce data and report on performance, measuring against set standards.

• Implement strategy to ensure Quality compliance at site level in line with our GEA Group global objectives and standards/measures.

• Work with the Management Teams to ensure timely closure of corrective actions arising from audits.

• Appoint and manage external advisors as well as establishing links to regulatory agencies and environmental authorities.

• Undertake and manage ‘risk assessments’ – ensuring that adequate resources are secured where necessary to ensure risk minimization.

• Provide a mix of policy development and implementation across all aspects of Quality.

• Ensure the effective implementation of GEA Group Quality Policies and Standards within the legal entity.

• Take ownership for successful delivery of legal entity wide Quality projects.

• Investigate systems’ failures and issues and coordinate continuous improvement.

• Guide, evaluate, and assist developing quality suppliers in NAM, in collaboration with Procurement and Supply Chain Functions.

• Organize Quality performance assessments.

• Communicate with internal and external clients on Quality issues.

Requirements:

• Bachelor’s of Science in Engineering, Pharmaceutical Sciences or similar, preferably with focus on Quality.

• 5+ years of experience in Pharmaceutical Equipment Manufacturing or Pharmaceutical Manufacturing required.

• 3+ years of experience dealing with ISO and FDA regulations required

• Must be willing to travel 20-25% of the time, both nationally and internationally

The typical base pay range for this position at the start of employment is expected to be between $90,00.00 - $125,000 per year.  GEA Group has different base pay ranges for different work locations within the United States.

The pay range is not a guarantee of compensation or salary.  The estimated range is the budgeted amount for the position. Final offers are based on various factors, including skill set, experience, location, qualifications, and other job-related reasons.  You may be eligible for additional rewards, such as discretionary bonus (based on eligibility) and/or equity awards.

GEA is an equal opportunity employer. Applicants will therefore receive consideration for employment without regard to age, sex, race, color, religion, world view, national origin, genetics, disability, gender identity, marital status, sexual orientation, veteran status or any other protected characteristic required by applicable law. Applicants with disabilities are welcome and will be given special consideration if they are equally qualified.