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. Serving as a technical resource within the Quality organization, the role ensures compliance with internal quality standards and applicable regulatory requirements. The position 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. It supports inspection readiness and business continuity while fostering a culture of quality excellence. The role may require travel to company locations, external meetings, and supplier sites.
Requirements
- Minimum of 5 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 organizational, analytical, and problem-solving skills.
- Strong verbal and written communication, interpersonal, and influencing skills; ability to interface with internal and external customers at all levels and communicate technical and non-technical information clearly.
- Excellent prioritization and organizational skills, including the ability to handle multiple priorities and projects simultaneously.
- Ability to think and act independently and make sound decisions.
- The position may require travel to other company locations, external meetings, and suppliers.
Nice To Haves
- A B.S. or B.A. in a science or engineering discipline is preferred.
Responsibilities
- Lead daily execution and continuous improvement of assigned Quality System processes.
- Maintain quality records in compliance with company procedures and regulatory requirements.
- Support inspection readiness and prepare for internal, customer, and regulatory audits.
- Identify opportunities to improve quality system effectiveness and efficiency.
- Lead investigations into deviations, nonconformances, complaints, and other quality events.
- Facilitate root cause analysis and develop effective corrective and preventive actions (CAPA).
- Monitor CAPA effectiveness and identify recurring trends requiring escalation or systemic improvement.
- Conduct risk assessments and make 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, and 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 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 in 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 in cross-functional project teams as the Quality representative and support product launches, transfers, supplier changes, and business initiatives.
- Recommend and implement process improvements across the External Quality network.
- Provide guidance to other team members.
Benefits
- Medical, dental, and vision coverage
- 401(k)
- Life, accident, and disability insurance
- Wellness programs
- For eligible roles, bonus and long-term incentive may be included in the total rewards package.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
