Manager, Quality Systems

Manager, Quality Systems

The Manager, Quality Systems is an on-site, Mon-Fri role, responsible for developing, implementing, and maintaining quality systems including but not limited to:

• Change Control
• Deviations / Investigations / OOS
• Corrective and Preventive Action (CAPA)
• Document Management and Control
• Record Management and Retention
• Training Management
• Product Quality Complaints
• Quality Metrics
• Management Review / Quality Review Board
• Internal Audit Program

Works with management and employees across the organization to ensure implementation of and compliance to an effective and compliant quality system to achieve business, operational, and quality goals.

The Manager, Quality Systems, is responsible for managing audits regulatory inspections and providing documentation support for regulatory submissions.

As needed, will support QA Operations activities including participation as quality representative on project teams supporting products in development, and performing quality functions including, but not limited to, product release and stability oversight.

Duties and Responsibilities:

• Serves as a leader for development, implementation, and continuous improvement of all quality systems.
• Responsible for maintaining document management systems for creation, approval, maintenance, issuance, control, and storage of GxP documents.
• Assists in establishing and delivering training programs and continuing education programs in the areas of quality assurance with emphasis on ensuring that the employee base has a clear understanding of regulatory quality system processes and tools including GxP requirements.
• Responsible for coordination and preparation for Management Review Meetings. Responsible for collecting key quality and compliance metrics for presentation of monthly Quality updates and Management Review meetings. Responsible for preparing minutes, action plans, etc. and following up to ensure resolution of issues. Responsible for setting up business tools and business processes to collect and capture Quality-related data to ensure reporting efficiency.
• Manages deviation, investigation, and product quality complaint programs
• Manages the change control and corrective and preventive action processes including leading teams, monitoring system performance, and reporting on progress.
• Manages the Internal Audit program, including scheduling, conducting audits, supporting investigation of findings, and approving compiled responses.
• Supports investigation and documentation of all product quality complaints. Works with Medical Affairs team who manages the relationship with contract pharmacovigilance provider.
• Recommends change and process improvements to the organizational quality management systems to ensure sustained compliance and operational efficiencies.
• Responsible for coordination and preparation for Quality Review Board Meetings. Responsible for preparing documents for discussion, attending, preparing minutes, and follow-up.
• Serves as interface to third party organizations and regulatory agencies, particularly during third party audits.
• Responsible for supporting audits and regulatory inspections and being part of the team that responds to findings. Responsible for managing audit/regulatory inspections. Responsible for follow-up and communication on actions committed as a result of audit/regulatory inspection.
• Participates in educational programs related to pharmaceutical activities which have special emphasis in quality assurance and compliance with regulations and standards.
• Based on changing regulatory requirements, assist and facilitate revising, improving, and developing programs, policies, and procedures to ensure sustained compliance of the quality system.
• Manage internal and third-party investigation and deviation meetings. Communicate product quality issues to management and provide information when out of specification results, investigations, or other issues impact batch disposition or the status of marketed batches.

Qualifications:

• Bachelor's Degree
• Minimum eight years experience in the pharmaceutical, medical device, vaccines, blood, or biologics industry.
• Minimum 5 years experience in quality assurance with quality systems responsibilities.
• Supervisory experience preferred.

Competencies:

• Knowledge of regulated quality systems management including but not limited to:
  Auditing, Document Control, Training System Administration, Customer Feedback, Deviation and Complaint investigation, Corrective and Preventive Action, Change Control, Handling Regulatory Inspections, Management Review
• Knowledge and experience in GxPs and with regulatory/accreditation agencies
• Knowledge of process design/redesign, performance measurement systems, and audit procedures and protocols
• Strong organizational skills
• Strong computer skills
• Ability to handle multiple projects
• Ability to manage technical personnel and information
• Ability to work independently with little direction

Technical Skills
- Assesses own strengths and weaknesses;
Pursues training and development…