Senior Manager/Associate Director - Quality Assurance
Senior Manager Quality Assurance Systems (GxP) 2004772
Location: Greater Boston, MA (Onsite/ Hybrid)
Science/ Focus: Biologics
Job Overview: Our client is looking to add a Senior QA Manager to their growing team to support and expand on the quality management systems and processes and be a key stake holder in driving the quality culture, including GxP compliance initiatives.
- Oversee the development and implementation of Quality systems including CAPA, deviation, risk analysis and change control management.
- Perform inspections and internal audits and participate in audit preparation
- Oversee qualification of equipment, systems and suppliers
- Create, revise, and review SOP’s, Training and work instructions
- Oversee qualification of equipment, systems, and suppliers
- Own and expand the QMS
- BS with 5+ years in biopharma Quality Assurance (Extensive experience within GLP or GMP preferred)
- Strong experience in Quality Systems- CAPA, deviation, risk analysis and change control management
- Experience preparing for and participating in GMP inspections by the FDA is highly preferred
- Experience driving the certification procedures for CLIA/ CAP is a plus
- Previous team leadership experience is preferred
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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