This role is primarily responsible for the ensuring compliance to FDA & Other regulatory bodies for the External Manufacturing Business
As the leader of the EMQA technical team, the individual must be able to mentor and coach a team of quality professionals to support process improvements, technical transfer, product/process changes, and new product development. Specifically,
• Support the business in leading process improvements by using Lean/six sigma tools to identify areas of improvement. Uses relevant statistical tools to analyze data for proactive improvements.
• Evaluate proposed changes and guides the external manufacturers, R&D, and technical operations in establishment of appropriate qualification, validation criteria.
• Support new product development within the external manufacturing space. Guides project team in development of qualification/validation plans. Ensure Quality by Design principles are employed and develop robust process control plans for tech transfer.
• Provide technical insight into non-conformance investigations. Work with External Manufacturers to identify the root cause and implement systematic corrective actions.
• Implement risk management program and tools to drive robust process and product controls.
• Identify opportunities to improve the overall performance of the EMQA network and reduce the Total Cost of Quality. Implement programs to continuously transition from failure and appraisal costs to prevention costs.
• Liaise with external audit agencies during inspections, recalls, etc.
BS Science, Engineering or Technical field.
Pharmaceutical, biologics, and/or medical device experience required. Knowledgeable in FDA/QSR requirements and quality system development/management. Experience with managing external agency audits necessary.
Experience with product and process validations in the pharmaceutical/medical device industry. Strong technical skills in the manufacturing of solid oral dose, semi-solids, devices, and biologics.
Knowledgeable of statistical techniques and application experience. Training and experience in statistics (DOE, SPC) preferred. Training in problem solving techniques or Lean Six Sigma Green belt preferred.
Lead auditor certification preferred.
Demonstrated project management and leadership skills, strong written and oral communication and interpersonal skills.
Previous experience mentoring and managing a team of professionals required. Training in coaching and management skills preferred, along with a proven track record of employee development.