Life Sciences Quality Leader

Charter Medical; Winston-Salem (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Generous Paid Time Off

Annual Bonus

401(k) with excellent company match

Health Insurance with multiple plans

Paid Short Term and Long Term Disabil“

Job summary

Charter Medical, part of the Solesis family, seeks a Life Sciences Quality Leader to drive Quality Operations including document control, QA, QE, and QMS compliance (ISO 13485, 21 CFR Parts 820, 210, 211). You will lead a team across two Winston-Salem facilities and partner with management to meet quality objectives.

The role emphasizes investigations, CAPAs, data-driven decisions, and cross-functional collaboration, with focus on regulatory alignment and continuous improvement.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5–8 years of Life Sciences, Single-Use Technologies & Medical Devices experience.
• 2–3 years of leading a team or managing direct reports.
• Strong working knowledge of ISO 13485 and quality-system requirements.
• Knowledgeable in 21 CFR 820 and cGMPs.

Responsibilities

• Promote and ensure regulatory and customer requirements awareness.
• Enforce quality policies and procedures to maintain product quality.
• Serve as QMS liaison between the organization and customers.
• Possibly act as Deputy Management Representative.
• Maintain ISO 13485 and compliance with 21 CFR Parts 820, 210, and 211.
• Lead Quality and Regulatory planning aligned with strategic objectives.
• Lead and contribute to complaint investigations and CAPAs with root cause analysis.
• Analyze quality data to identify risks and drive corrective actions.
• Manage definitive work plans with owners, milestones, and deadlines.
• Oversee investigations, ensure technical adequacy and timely completion.
• Communicate findings and business impact to leadership.

Skills

Quality leadership

ISO 13485

Regulatory knowledge

Audits

cGMP knowledge

Education

Bachelor's degree in Engineering

Job description

Charter Medical, part of the Solesis family of companies, specializes in single-use solutions that enable life sciences innovators to turn bold ideas into lasting breakthroughs, supporting industry-leading companies in bringing life-saving therapies to market. Operating in North Carolina, Charter Medical employs more than 150 team members across two facilities in Winston-Salem.

Guided by a commitment to quality, innovation and customer success, Charter partners with customers to transform promising therapies into commercial realities. Employees contribute to solutions that support life-changing treatments and make a meaningful impact on patients around the world.

1st shift Monday-Friday 8:00 am-5:00 pm

About the role:

The Life Sciences Quality Leader is responsible for leading the Quality Operations at Charter Medical, including Document Control, Quality Assurance, Quality Engineering, and all QMS requirements including but not limited to internal/external audits, document control, product release, complaints, CAPA, NCRs, deviations, inspections, Management Review, training, regulatory reporting obligations PMS, labelling, sterilization and environmental monitoring programs. The position meets the Company’s quality objectives directly or through subordinate supervisors or individual contributors.

What you will do:

• Ensures the promotion and awareness of regulatory and customer requirements.
• Maintains 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 in the capacity of Deputy Management Representative or designee.
• Responsible for maintaining ISO 13485:2016 and compliance with 21 CFR Parts 820, 210, and 211.
• Lead the Quality and Regulatory Planning in conjunction with the company’s strategic objectives.
• Leads and personally contributes to complaint investigations and CAPAs, ensuring evidence-based root cause analysis, appropriate containment, corrective actions, and effectiveness verification. Reviews investigations for technical adequacy and ensures completion within established deadlines.
• Owns the accuracy, completeness, and timely reporting of quality metrics. Analyzes complaint, nonconformance, supplier, and internal scrap data to identify emerging risks, evaluate corrective-action effectiveness, and recommend actions. Clearly communicates findings, business impact, and limitations to leadership.
• Establishes and maintains a prioritized departmental work plan with defined owners, milestones, and deadlines. Monitors progress, addresses overdue work and backlogs, and escalates risks before commitments are missed, with proposed recovery actions and resource needs.
• Maintains sufficient technical knowledge to independently evaluate investigations, challenge conclusions, and make quality decisions. Directly completes critical deliverables when needed and remains accountable for the quality and timeliness of delegated work.
• Leads cross-functional quality reviews with clear objectives, decisions, action owners, and follow-up. Uses meeting participation and team resources effectively while maintaining adequate time for investigations, technical reviews, and completion of priority work.
• Identify and communicate changes to standards and regulatory requirements.
• Responsible for ensuring the conformity of products is appropriately checked per quality system requirements before the release and, when necessary, certifies finished goods.
• Review and authorize deviations and, when necessary, facilitate appropriate review boards for deviations and specification changes.
• Collaborates cross-functionally with other members of management to develop new products and engineering designs.
• Review and support customer advisories, post-market surveillance, and is responsible for the disposition of authorization returns as applicable.
• Assist manufacturing teams with continuous improvement initiatives.
• Monitor nonconforming product disposition and control, advise senior management, as necessary.
• Support the evaluation of raw material out of specifications and determining the disposition of any rejects, quarantines, etc.
• Ensures label claims and content of promotional materials meet statutory and regulatory requirements.
• Partner with Human Resources to maintain adequate staffing levels for the Quality Team.
• Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement.
• Completes performance appraisals and reviews with employees; recommends salary increases to management and HR.
• Provides input to the department budgeting process and monitors and controls expenses throughout the year to meet budget requirements.

Please note that Charter Medical does not provide employment visa sponsorship for this position. Candidates must be authorized to work in the United States without sponsorship both now or in the future.

Who you are:

• Bachelor’s degree (B.S.) in an Engineering discipline.
• Five (5) to eight (8) years of related experience in Life Sciences, Single-Use Technologies & Medical Devices.
• Two (2) to Three (3) years of leading a team or managing direct reports.
• The 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.
• Knowledgeable in 21CFR820and cGMP’s.
• Demonstrated success managing competing priorities, reducing backlogs, and meeting quality-system and customer deadlines.
• Proven ability to independently lead complex quality activities from problem identification through implementation and effectiveness verification.
• Excellent interpersonal skills with proven ability to get along well with others and work 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 with the ability to work in a high-paced environment with limited direction.
• Demonstrated 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.
• Generous Paid Time Off
• Annual Bonus
• 401(k) with excellent company match
• Health Insurance with multiple plans to choose from
• Paid Short Term and Long Term Disability