Skip to content
Associate Director – Quality Operations
| Company | Vertex Pharmaceuticals |
|---|
| Location | Boston, MA, USA |
|---|
| Salary | $152200 – $228300 |
|---|
| Type | Full-Time |
|---|
| Degrees | Bachelor’s |
|---|
| Experience Level | Senior, Expert or higher |
|---|
Requirements
- Bachelor’s degree in an engineering/scientific discipline, or a related field
- +8 years of relevant experience or the equivalent combination of education and experience
- Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams
- Knowledge of global GMP requirements governing CGT products
- Ability to evaluate quality matters and make decisions utilizing a risk-based approach
- Strong technical knowledge including but not limited to: training, document control, and quality governance
- Solid quality culture knowledge and understanding of how to influence and improve overall compliance
- Superb facilitation, communication, and coaching/influencing skills with proven ability to lead teams
- Experience across multiple GxP areas
- Proven ability to identify and analyze performance indicators
- Strong leadership skills with the ability to thrive in a high throughput environment with competing priorities
Responsibilities
- Contributes to the advancement and compliance of the site documentation and training programs by identifying opportunities and supporting risk-appropriate enhancements in line with the Global Quality systems
- Management of the documentation process including reconciliation of batch records, logbooks, and other GMP documentation
- Partner with internal manufacturing to implement, develop and lead the monitoring of key quality system tiered metrics and risks to ensure the site operational execution is in a state of control
- Coordinates and oversees training activities together with the internal manufacturing coordinator within a GxP environment
- Work with global quality and functional areas to ensure program is aligned to Vertex standards while also being scalable and flexible
- Participate with stakeholders on operational vendor related issues impacting the site manufactured product
- Monitors performance of vendors through operational feedback contributing operational input to the Global Vendor process as well as addressing SCARs, and other inputs
- Ensures escalation and compliant governance
- As a people manager within the organization, provides leadership, development and coaching to staff
- Ownership of the Document Control Room at LC1 including cleanliness, organization, supply inventory, and room access
- Gather stakeholder feedback to improve and gain efficiencies
- Act as the operational site quality system SME for QS and strategic support to functional areas
- Clearly communicate program and status updates to managers, leadership, the Quality team, and stakeholders
- Responsible for proper archiving of GMP documentation, including scanning and storage to Fan Pier
Preferred Qualifications
- Ability to lead and manage projects/teams with incorporated objectives and project timelines
- Successful in mentoring people managers
- Collaboration/Teamwork/Conflict Management
