Senior Director - Site Quality Operations
Senior Director Site Quality Operations
Our client started with a mission to develop meaningful innovations that truly enhance patients care, creating a healthier society.
They are a world leader in specialized diagnostics, operating globally via direct and distributor markets with technology centers in Europe and the US driving sales north of $2 billion pa.
To continue their desired growth, we are supporting them in the search for a Senior Director -Site Quality Operations based Middlesex County MA.
This is a fantastic platform for continued career development for a quality leader seeking a challenging opportunity, the chance to make a real business impact and to enhance their career.
This role will be responsible for leading all site quality functions as well as fulfilling quality assurance obligations to appropriate regulatory bodies, serving as the Management Representative.
Reporting to the Executive VP of Global QA & RA, with a quality team of circa 50 this role will be tasked with driving improvements across the quality organization, enhancing business tools, integrating systems, succession planning, taking the team to maximize potential across all areas of QMS, Validation, Document Control, Quality Engineering, Compliance etc.
Do you have :
- Bachelor’s Degree (Engineering or Life Science) required.
- Fifteen (15) years’ relevant experience in medical devices or other regulated industry.
- Previous experience in a quality or regulatory leadership position in a diagnostic or medical device manufacturer required.
- Expert level understanding of US FDA Quality System Regulations, ISO 13485, in EU MDR and IVDR.
- Excellent presentation, negotiation, conflict resolution skills with strong written / verbal communication skills across leadership levels.
- Ability to identify opportunities for creating compliant systems in a new, rapidly changing product and regulatory environment.
- Demonstrated continuous improvement, change management exposure Quality organization in a manufacturing environment.
This will be a highly visible role with long-term growth opportunities. If you have the drive, mentality and expertise to take on a new, exciting opportunity please reach out for further information and a conversation.
Senior Director - Global Clinical Operations
Lead clinical operations globally to support the scope of our clinical development programs including development of both office and field-based clinical operations staff. Provide clinical operations support and management for all study activities including site identification and selection, enrollm...
Senior Director of Revenue Operations
The Senior Director of Revenue Operations at Allego is responsible for ensuring the smooth and efficient functioning of the Sales and Marketing teams through effective processes, tools, and analytics. This role also involves developing revenue strategies, managing sales operations, overseeing market...
Director, Quality Operations
This position is responsible for the oversight and management of the deliverables of the Quality Assurance, Document Control, and Quality Supplier Management departments which includes disposition of in-process materials and finished product, labeling and documentation, deviations, CAPAs and product...
Restaurant Operations Director
The Director of Restaurant Operations is responsible for the day-to-day operations and staffing for the kitchen and various dinning services of the community. Primarily for planning, organizing, and directing the Restaurant Operations department to provide the residents with the highest quality-dini...
Executive Director of Operations
As an Executive Director of Operations for Benchmark Senior Living, you will have the opportunity to improve the quality of life of the Senior Citizens living in your community. As an Executive Director of Operations, you will authorize all purchases, provide onsite sales support, and conduct monthl...
Senior Director Manufacturing Operations
Develop the site Operations strategy across disciplines in Taunton Manufacturing in collaboration with functional partners in global operations. Develop and deploy multi year roadmap and strategies for Taunton operations, to achieve long terms goals and short term targets of Global operations for Su...
Senior Director, Commercial Strategy and Operations
The Senior Director of Commercial Strategy & Operations is responsible for ensuring the Biogen North America (BNA) Organization is best positioned to deliver on its business objectives by establishing clear strategic priorities, driving execution effectiveness, and spearheading innovation across the...
Senior Director Regional Operations
Senior Director Regional OperationsSalem, OR. Join our team as a Senior Director Regional Operations at the Lancaster Family Health Center at Lancaster in Salem, OR, . Manages all workflows at the site, including the clinic billing process for all applicable service lines within the site. Increased ...
Senior Director -Trades Operations
Reporting to the Associate Vice-President of Facilities Operations, the Senior Director will oversee the maintenance and operations of the Massachusetts campuses, including direct supervision of Facilities trades shops covering carpentry/paint, lock, electric, mechanical/plumbing, HVAC, life safety,...
Director, Apheresis Quality Operations (Hybrid)
The Director, Cell & Gene Quality, International will support defining the strategy for the international expansion of Cell & Genetic programs. The role will closely partner with operational stakeholders to lead/support the development and execution of quality projects, quality & technical risk mana...