Quaility System and Standards Manager- BioScience

Job Summary

Ready to make a real difference in the world of pharmaceutical and medical device manufacturing? Smithfield Bio Science, Inc. (SBC) is seeking a quality-driven professional for a full-time role reporting to the Senior Quality Assurance Manager — a position that is important to our mission to deliver products that meet the highest global standards.

• The Quality Systems and Standards Manager (QSS) will be the Site Owner of the Quality Management System (QMS).
• The Manager will be responsible for Systems, Standard Operating Procedures and Tools to be in place and in use as well as being properly maintained.
• The Site QSS Manager is responsible for Continuous Improvement activities through participation in the Site Quality Council as well as administration of the Site Quality Road Map.
• Be a leading advocate of the Quality Culture within the QA Function as well as the Site. Promote the values of a Learning Organization.
• Provide coaching/feedback to enhance the QA group and individuals’ professional performance and development.
• Serving as a strategic partner, Champion a culture of quality-first thinking, driving Quality Excellence across departments.

• QMS Maintenance: Maintain the Site Quality Management System (QMS) in a state of compliance with all applicable Regulations.
• QMS Governance: Administer Site QMS governance through management reviews to ensure its continuing suitability and effectiveness.
• Process Management: Develop and use effective monitoring and controls for key QMS processes (i.e. Deviations, Change Control; CAPAs).
• Metrics: Through Key Quality Performance Indicator (KPI) Dashboard, monitor Site quality systems performance.
• Data Integrity: Provide specific Site Wide data integrity (DI) awareness and training on an annual basis.
• Complaint Management: Responsible for the management of customer complaint handling process for the site.
• QMS Fit for
  
  Purpose:
  
  Monitor Internal and External Factors Impacting the Quality Management System (i.e. emerging regulations, innovations that might impact the Site QMS). Stay current with evolving FDA, EU, and ICH regulations, ensuring company procedures remain aligned with global expectations.

• Quality Council Owner: Participate and manage the Site’s Quality Council as the process owner for Quality Planning and the QMS.
• Quality Council Reviews: Drive actions as a result of the Quality Council metrics reviews of Key QMS processes.
• Compliance
  
  Risk Management:
  
  Identify and communicate potential compliance gaps / risks to management. Develop and maintain the site Risk Register.
• Site Quality Plan: Develop, oversee and monitor the Site Quality Plan/Roadmap. (Site Quality Leader is Accountable, QMS Manager is Responsible)
• Validation Master Plan: Responsible for preparation and maintenance of the site Validation Master Plan in line with current requirements. The VMP must be established and kept up to date by the site operations leader (e.g. head of manufacturing/technical services) and the responsible Quality Assurance Operations manager and Quality Control manager.

• SOP Maintenance: Oversee the governance of Standard Operating Procedures (SOPs) sitewide.
• SOP Governance: Ensure SOPs are reviewed on prescribed periodic basis. Monitor SOPs for relevance, completeness, and appropriate use.
• Quality Agreements: Maintain Technical Quality Agreement (TQA) templates for use with customers and suppliers.

• QMS & Tech Proficiency – Experience with digital quality systems like Track Wise Digital or similar platforms.
• Sets Clear Direction and Aligns Team and Others Around Common Objectives.
• Coach and mentoring – enhance the skills of the QSS staff for GMP fluency and overall professional development.
• Knowledge / Expertise in Pharmaceutical Manufacturing Processes.
• Experience in writing and editing technical documents.
• Familiarity with risk management principles and tools, including FMEA (Failure Modes and Effects Analysis) and risk assessment methodologies.
• Exceptional Communicator – Strong…