Sr. Quality Specialist
About The Position
The Senior Quality Specialist leads and coordinates key Quality System activities supporting contract manufacturing organizations, contract packaging organizations, suppliers, and distribution partners. As a technical resource within the Quality organization, the role ensures compliance with internal quality standards and applicable regulatory requirements. The specialist independently manages complex quality system activities, leads investigations and continuous improvement initiatives, drives issue resolution with internal and external partners, and guides other team members. The position supports inspection readiness and business continuity while fostering a culture of quality excellence. The role covers quality systems management; investigations, CAPA, and risk management; external partner quality oversight; audit and compliance support; documentation and data management; and continuous improvement and project leadership. It also supports product launches and transfers, process and supplier changes, and cross-functional business initiatives. Travel to other company locations and external meetings or suppliers may be required.
Requirements
- Minimum five years of experience in Quality Assurance, Quality Systems, Supplier Quality, Manufacturing Quality, or a related discipline.
- Knowledge of regulated products and quality systems, including Health Canada and FDA requirements.
- Experience with investigations, CAPA, change control, and document management processes.
- Strong verbal and 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, and problem-solving skills, including the ability to handle multiple priorities and projects simultaneously.
- Ability to think and act independently and make sound decisions.
Nice To Haves
- B.S. or B.A. in a science or engineering discipline preferred.
Responsibilities
- 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 and preparation for internal, customer, and regulatory audits.
- Identify opportunities to improve quality system effectiveness and efficiency.
- Independently lead investigations related to deviations, nonconformances, complaints, and quality events.
- Facilitate root cause analysis and develop 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.
- 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.
- Participate in internal, supplier, and third-party audits.
- Assist with 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.
- 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.
- Lead quality improvement initiatives focused on compliance, efficiency, and risk reduction.
- Participate on cross-functional project teams as the Quality representative.
- Recommend and implement process improvements across the External Quality network.
- Provide guidance to other team members.
- Travel to other company locations and external meetings or suppliers as may be required.
Benefits
- Medical, dental, and vision coverage
- 401(k)
- Life, accident, and disability insurance
- Wellness programs
- Eligible roles may also include a bonus and long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Senior
