Sr. Quality Specialist

Position Summary

The Senior Quality Specialist is responsible for leading and coordinating key Quality System activities in support of contract manufacturing organizations, contract packaging organizations, suppliers, and distribution partners. The role serves as a technical resource within the Quality organization and is responsible for ensuring compliance with internal quality standards and applicable regulatory requirements.

The Senior Quality Specialist independently manages complex quality system activities, leads investigations and continuous improvement initiatives, drives issue resolution with internal and external partners, and provides guidance to other team members. The position plays a critical role in maintaining inspection readiness, supporting business continuity, and fostering a culture of quality excellence.

Essential Functions:

Quality Systems Management

• Lead daily execution and continuous improvement of assigned Quality System processes.
• Ensure quality records are maintained in compliance with company procedures and regulatory requirements.
• Support inspection readiness activities and preparation for internal, customer, and regulatory audits.
• Identify opportunities to improve quality system effectiveness and efficiency.

Investigation, CAPA & Risk Management

• Independently lead investigations related to deviations, nonconformances, complaints, and quality events.
• Facilitate root cause analysis and development of effective corrective and preventive actions.
• Monitor CAPA effectiveness and identify recurring trends requiring escalation or systemic improvement.
• Conduct risk assessments and provide recommendations using science and risk-based decision-making principles.

External Partner Quality Oversight

• Support quality oversight of suppliers, contract manufacturers, co-packers, and distribution partners.
• Participate in supplier performance monitoring and quality reviews.
• Collaborate with external partners to resolve quality concerns and implement improvements.

• Support supplier qualification, change management, and ongoing performance evaluations.

• Support new product introductions, product transfers, process changes, and supplier changes.

Audit & Compliance Support

• Participate in internal, supplier, and third-party audits.
• Assist in audit preparation, response development, and corrective action implementation.
• Track audit findings and support timely closure of commitments.
• Ensure compliance with applicable FDA, Health Canada, GMP, and company quality requirements.

Documentation & Data Management

• Review, develop, revise, and maintain quality procedures, specifications, work instructions, and quality records.
• Ensure documentation is accurate, complete, and maintained within approved systems.
• Analyze quality metrics and trend data to identify improvement opportunities.
• Prepare reports, presentations, and quality summaries for management review.

Continuous Improvement & Project Leadership

• Lead quality improvement initiatives focused on compliance, efficiency, and risk reduction.
• Support product launches, product transfers, supplier changes, and business initiatives.
• Participate on cross-functional project teams as the Quality representative.
• Recommend and implement process improvements across the External Quality network.

Experience/Education Required:

• Minimum B.S. or B.A. – Science or Engineering Degree preferred
• Minimum 5 years of experience in Quality Assurance, Quality Systems, Supplier Quality, Manufacturing Quality, or a related discipline.
• Knowledge of regulated products and quality systems. (Health Canada, FDA, etc.)
• Experience with investigations, CAPA, change control, and document management processes.
• Strong organizational, analytical, and problem-solving skills.

Skills and Abilities Required: 

• Strong verbal / written communication, interpersonal, and influencing skills. Ability to interface with internal and external customers at all levels. Ability to clearly communicate technical and non-technical information verbally and in writing.
• Excellent organizational, prioritization skills and problem-solving skills to successfully handle multiple priorities and projects simultaneously.
• Ability to think and act independently and make sound decisions. 
• The position may also require travel to other company locations and to external meetings, suppliers, etc.

The salary range for this position is $84,000–$126,000.

Compensation for this position varies based on a range of equal opportunity factors, including but not limited to role scope, level of experience, relevant skills, education and credentials, external and internal benchmarks for equivalent roles and experience, business sector, and geographic location. Compensation decisions are based on the specific facts and circumstances of each case. In addition to base salary, the total rewards package may also include, for eligible roles, bonus, and long-term Incentive. Edgewell offers competitive employee benefits, including medical, dental & vision coverage; 401(k); life, accident, and disability insurance; and wellness programs. Your Talent Acquisition Partner can provide additional details regarding total rewards offerings and the applicable salary range for the relevant location(s) during the hiring process.

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