Supervisor, Quality Systems Engineering Job in Lexington 02421, Massachusetts Us
Summary:
· Manage/Lead Change Control, CAPA, Deviation, Investigation Systems ensuring appropriate follow up and on time closure
· Implement process/system improvements, as required
· Manage/Lead Validation system including equipment, process, and computer system validation programs
· Support/Lead internal and external vendor audits, as needed
· Create/revise Standard Operating Procedures and other controlled documentation
Requirements:
· BS degree in Biological Science, Chemistry, Engineering or related field
· 5-7 years experience in Quality Assurance with at least 3 years managing Quality Systems
- Excellent verbal and written communication skills
- Ability to work collaboratively in a cross functional team environment
- Ability to manage direct reports efficiently
- Ability to travel domestically and internationally (travel up to 20%)
- Knowledge of FDA, ICH, Health Canada, EMA regulations as related to pharmaceutical manufacturing
Essential Functions
· Manage/facilitate change control review board
· Manage/facilitate CAPA, Deviation, Investigation systems
· Create and report/present quality system metrics to Corporate Quality Council
· Create/revise validation master plans and associated procedures
· Collaborate with internal departments to determine appropriate CAPA plans and ensure effectiveness checks, as required
· Coordinate internal support (back room activities) during Regulatory Inspections
· Support/conduct external vendor audits
Other duties as assigned by the Sr. Director Quality and Compliance
Please apply via our website: www.amagpharma.com