Life Sciences Quality Leader

Solesis•Winston-Salem, NC

About The Position

The Life Sciences Quality Leader leads Quality Operations at Charter Medical, including Document Control, Quality Assurance, Quality Engineering, and the company’s quality management system (QMS). The role oversees requirements and activities such as internal and external audits, product release, complaints, CAPA, nonconformance reports, deviations, inspections, Management Review, training, post-market surveillance and regulatory reporting, labeling, sterilization, and environmental monitoring. The position meets the company’s quality objectives directly and through subordinate supervisors or individual contributors. The leader maintains product quality and regulatory compliance, including ISO 13485:2016 and applicable FDA regulations, and serves as a quality liaison with customers. The role leads quality and regulatory planning, investigations and corrective actions, quality metrics and risk analysis, cross-functional reviews, and departmental work planning. It also supports product development, manufacturing improvement, product disposition, staffing and development of the Quality Team, employee performance management, and department budgeting.

Requirements

Bachelor’s degree (B.S.) in an Engineering discipline.
Five to eight years of related experience in Life Sciences, Single-Use Technologies, and Medical Devices.
Two to three years of experience leading a team or managing direct reports.
Ability to understand and enforce regulatory requirements.
Working expertise in ISO 13485 and applicable quality-system requirements, including practical application to investigations, audits, product disposition, and quality decisions.
Knowledge of 21 CFR 820 and cGMPs.
Demonstrated success managing competing priorities, reducing backlogs, and meeting quality-system and customer deadlines.
Ability to independently lead complex quality activities from problem identification through implementation and effectiveness verification.
Excellent interpersonal skills and ability to work well with others in a team environment.
Excellent verbal and written communication skills.
Excellent customer service focus and professionalism.
Ability to independently prioritize and execute projects and responsibilities.
Self-starter able to work in a fast-paced environment with limited direction.
Ability to establish accountability, exercise sound judgment, and develop a technically capable quality team.
Experience conducting and reviewing root cause investigations using structured problem-solving tools and objective evidence.
Experience analyzing quality data, reconciling source records, and presenting actionable conclusions to senior leadership.
Experience managing employee performance, including addressing missed commitments and inadequate work quality.
Must be authorized to work in the United States without employment visa sponsorship now or in the future.

Responsibilities

Promote awareness of regulatory and customer requirements and maintain product quality by enforcing quality policies, procedures, and applicable statutory and regulatory requirements.
Act as the Quality liaison between the organization and customers; may serve as Deputy Management Representative or designee.
Maintain ISO 13485:2016 compliance and compliance with 21 CFR Parts 820, 210, and 211.
Lead Quality and Regulatory Planning in conjunction with company strategic objectives.
Lead and contribute to complaint investigations and CAPAs, ensuring evidence-based root cause analysis, containment, corrective actions, effectiveness verification, technical adequacy, and timely completion.
Own accurate, complete, and timely quality metrics; analyze complaint, nonconformance, supplier, and internal scrap data to identify risks, assess corrective-action effectiveness, recommend actions, and communicate findings to leadership.
Establish and maintain a prioritized departmental work plan with owners, milestones, and deadlines; monitor progress, resolve overdue work and backlogs, and escalate risks with recovery actions and resource needs.
Maintain technical knowledge to evaluate investigations, challenge conclusions, make quality decisions, complete critical deliverables when needed, and remain accountable for delegated work.
Lead cross-functional quality reviews with clear objectives, decisions, action owners, and follow-up.
Identify and communicate changes to standards and regulatory requirements.
Ensure product conformity is checked under QMS requirements before release and certify finished goods when necessary.
Review and authorize deviations and facilitate review boards for deviations and specification changes when necessary.
Collaborate with management on new products and engineering designs.
Review and support customer advisories and post-market surveillance, and disposition authorization returns as applicable.
Assist manufacturing teams with continuous improvement initiatives.
Monitor nonconforming product disposition and control, advise senior management as necessary, and support evaluation and disposition of out-of-specification raw materials and rejected or quarantined items.
Ensure label claims and promotional material content meet statutory and regulatory requirements.
Partner with Human Resources to maintain adequate Quality Team staffing.
Coach, provide feedback and guidance to team members, and develop, monitor, and update career plans.
Complete employee performance appraisals and reviews and recommend salary increases to management and Human Resources.
Contribute to department budgeting and monitor and control expenses to meet budget requirements.