Quality Assurance Sr. Supervisor
Saint Louis, Missouri, United States
Job type: fulltime
Job industry: Other
The Quality Assurance Sr. Supervisor is responsible for ensuring quality and regulatory compliance in accordance with customer requirements, company policies, and domestic (US FDA) and International standards (ISO 9001, 13485). Under the direction of the Site Head of Quality, the Quality Assurance Sr. Supervisor works as a collaborative team member and leader to deliver site goals and objectives to drive business results and continuous improvement culture.
Specific Tasks, Duties, and Responsibilities:
- Lead, manage, and develop staff. Hire, train, and develop qualified staff to ensure effective execution of tasks, regulatory compliance, and attain operational and development goals.
- Drive achievement of site vision and goals/objectives.
- Manage the implementation of quality management systems (QMS) in alignment with corporate standards. Support ongoing quality system improvement programs and initiatives.
- Drive improvement in customer experience - complaint reduction, supply reliability, field actions, audit performance, etc.
- Coordinate the investigation and closure of deviations with specific emphasis on comprehensive root cause analysis. Ensure appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented and monitored.
- Develop and implement standardized metrics that guide actions and promote continuous improvement.
- Implement and maintain tracking and trending to identify potential out of trend conditions and proactively mitigate.
- Review and approve documents such as SOPs, validation protocols and reports, deviation/CAPA plans, and change controls to ensure compliance.
- Participate and/or lead internal and external audits.
- Function as the Quality department liaison to other departments including but not limited to Quality Control, Manufacturing Operations, New Product Development, Regulatory and Supplier quality.
- Participate in FDA and ISO 9001 / ISO 13485 inspections as required.
Who You Are:
- Bachelor's Degree in Chemistry, Biochemistry, Biology, or another life science discipline.
- 5+ years of quality experience within the life science industry.
- 5+ years' experience leading people and/or departments.
- 5+ years' experience leading a quality organization in a manufacturing setting such as; Quality Ops, QC Labs, Quality Management Systems, Validation, Supplier Management.
- Experience working w/ customers and internal/external stakeholders
- Proven strong leadership skills w/ ability to motivate, inspire, and build a high performing team. Demonstrated ability to drive "followership".
- Strong command of quality systems supporting ISO 9001, ISO 13485, FDA regulations (such as 21CFR820, 21CFR 210 & 211). MDSAP a strong plus.
- Certifications: CMQ/OE, CQE, CQA, CQPA a plus
- Strong written and verbal communication skills
- Ability to manage in a complex, matrixed, and fast-paced environment. Able to triage workload effectively to drive departmental focus.
- Requisite confidence and experience to drive effective, pragmatic, and risk-based decisions.
- High intellectual horsepower and proven problem-solving ability. A good decision-maker.
- Collaborative and motivated team player. Always looking to share and advance best practices.
- Ability to drive change and challenge the status quo in a respectful/professional manner.