Quality Manager

Your Role:

The Quality Manager plans and directs activities to ensure product reliability and conformance to cGMP, as well as Customer/Regulatory specifications. The Quality Manager works as a collaborative team member and leader to establish department goals and objectives to drive business results and a continuous improvement culture. 

Essential Job Functions:

• Lead, manage and develop qualified staff to ensure effective execution of tasks, cGMP compliance, and to attain operational and development goals.
• Drive improvement in customer experience – complaint reduction, supply reliability, field actions, audit performance, etc.
• Provide sound quality input to validation planning and execution, including R&D product transfers.
• Provide support to Engineering and Operations groups in troubleshooting and development of process technology and continuous improvement programs. Utilize sound statistical based facts to bring value to the customer.
• Drive product and process improvements through thorough investigations and effective root cause analysis. Drive risk mitigation and effective process controls.
• Develop and implement standardized metrics that guide actions and promote continuous improvement (e.g. FPQ, CAPA, etc).
• Implement and maintain tracking and trending to identify potential out of trend conditions and proactively mitigate.

Who You Are

Minimum Qualifications:

• BS degree in a scientific or technical discipline; Engineering discipline preferred.
• 3+ years’ experience leading an organization in a manufacturing setting with proven track record of successful performance.

Preferred Qualifications:

• MS, MBA or PhD
• Experience developing organizational vision and supporting goals and objectives. Track record of driving successful change initiatives that have resulted in favorable business outcomes.
• Experience working with customers and internal/external stakeholders from different geographies. Cultural sensitivity and awareness.

• Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211) Black Belt or Green Belt a plus

• Proven strong leadership skills w/ ability to motivate, inspire, and build a high performing team. Demonstrated ability to drive “followership”.
• Requisite confidence and experience to drive effective, pragmatic and risk-based decisions.
• High intellectual horsepower and proven problem solving ability. Good decision maker.
• Collaborative and motivated team player. Always looking to share and advance best practices.
• Up to 10% travel, domestic and international