Manager, Manufacturing Quality

Leadership Accountabilities:
- Lead coach and develop Quality team members through clear priorities regular feedback effective delegation and meaningful growth opportunities.
- Create an energized accountable quality culture in which employees understand requirements raise concerns early and participate in solutions.
- Serve as an influential member of the site leadership team translating quality priorities into practical manufacturing plans and measurable results.
- Build strong partnerships with Manufacturing Supply Chain R&D and affiliated Quality teams to align decisions remove barriers and standardize practices across Stago companies.
- Communicate quality performance risks resource needs and improvement priorities clearly to employees and senior leadership.
- Lead through change by establishing direction engaging stakeholders employ automated workflows and sustaining new ways of working.

Manufacturing Quality Responsibilities:
- Provide day-to-day Quality leadership for manufacturing operations at DSRV Inc. including floor presence escalation support disposition decisions QMS training and timely resolution of production issues.
- Manage the QMS integration between DSRV Inc. and Stago North America.
- Ensure quality requirements are met for incoming materials in-process activities and final release of manufactured products.
-Maintain responsibility for final product release.
- Strengthen production controls inspection methods acceptance criteria sampling approaches and manufacturing documentation to support consistent execution.
- Partner with Operations and R&D on process validation equipment qualification calibration maintenance interfaces and change implementation.
- Lead investigations of nonconformities deviations complaints and recurring manufacturing issues. Ensure root causes are evidence-based and actions are effective.
- Own and improve the CAPA system including prioritization investigation quality action planning effectiveness checks timeliness and lean documentation.
- Use quality metrics and trend data to identify risk focus resources improve right-first-time performance and prevent recurrence.
- Drive supplier quality activities including qualification performance monitoring issue escalation corrective action and supplier audits in partnership with Supply Chain.
- Lead internal audit activities and management review inputs with an emphasis on manufacturing performance system effectiveness risk and improvement opportunities.
- Maintain effective document control training records risk management and validation practices that support disciplined quality
- Champion Lean and continuous improvement methods that reduce variation simplify work strengthen controls and improve the employee and customer experience.
- Ensure readiness for customer certification and regulatory inspections. Coordinate responses and follow-up actions related to manufacturing and Quality systems.
- Provide regulatory documentation or agency support as needed in partnership with US Market Access.

-Serve as Management Representative for DSRV Inc. and Deputy Management Representative for Stago North America.

-Ensure Quality is integrated into daily manufacturing decisions instead of inspected in after the fact.

-Ensure issues are surfaced early investigated thoroughly and resolved with durable corrective action.

-Quality metrics drive focused action and demonstrate improving process control and product consistency.

-Ensure the site is consistently ready for audits and inspections because strong daily execution is the norm.