Life Sciences Quality Leader

Solesis•Winston-Salem, NC

3d•Onsite

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 audits, product release, complaints, CAPA, nonconformance reports, deviations, inspections, management review, training, regulatory reporting obligations, post-market surveillance, labeling, sterilization, and environmental monitoring programs. The position achieves the company’s quality objectives directly and through subordinate supervisors or individual contributors. The leader maintains product quality and regulatory compliance, serves as the Quality liaison with customers, and may act as Deputy Management Representative or designee. The role requires maintaining ISO 13485:2016 and compliance with 21 CFR Parts 820, 210, and 211, while aligning Quality and Regulatory Planning with company strategy. It also involves leading investigations and corrective actions, monitoring quality metrics and work plans, supporting product and process decisions, and developing the Quality team. This is a first-shift position, Monday through Friday, 8:00 a.m. to 5:00 p.m. Charter Medical does not provide employment visa sponsorship; candidates must be authorized to work in the United States without sponsorship now or in the future.

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.
Demonstrated 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 effectively 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.
Demonstrated 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.
Demonstrated 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 enforce 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 and compliance with 21 CFR Parts 820, 210, and 211.
Lead Quality and Regulatory Planning in alignment with company strategic objectives.
Lead and contribute to complaint investigations and CAPAs, including evidence-based root cause analysis, containment, corrective actions, and effectiveness verification.
Review investigations for technical adequacy and ensure completion by established deadlines.
Own the accuracy, completeness, and timely reporting of quality metrics; analyze complaint, nonconformance, supplier, and internal scrap data to identify risks and recommend actions.
Communicate findings, business impact, and limitations to leadership.
Establish and maintain a prioritized departmental work plan with owners, milestones, and deadlines; monitor progress, address overdue work and backlogs, and escalate risks with recovery actions and resource needs.
Independently evaluate investigations, challenge conclusions, make quality decisions, and complete critical deliverables when needed; 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 appropriately checked before release and, when necessary, certify finished goods.
Review and authorize deviations and facilitate review boards for deviations and specification changes when necessary.
Collaborate with management colleagues 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 materials.
Ensure label claims and promotional materials 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.
Provide input to departmental budgeting and monitor and control expenses to meet budget requirements.