Quality Systems Manager

Quality Systems Manager

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.

Job Summary

The Quality Systems Manager oversees the process and management of systems, deviation management, change control, risk, documentation, and supplier management. This position is the main contact for customer audits and regulatory inspections, and is responsible for CAPA plan establishment, and execution of them on time. The Quality Systems Manager is responsible for overseeing the site housekeeping thanks to a strong internal audit schedule. Thanks to the central position, this manager is the Quality Management System owner, through a dashboard presented periodically. Thanks to this position too, he/she will be able to identify areas of improvement. This position interacts with everyone (leadership team, managers, operators…) and must have a strong leadership to manage a team, many different topics and timelines.

Essential Functions / Responsibilities

• Human Resources Management
  • Ensure that the team's training is appropriate for executing the missions.
  • Conduct annual interviews to assess team development and performance.
  • Define priorities in handling the resources and the deadlines.
  • Develop the skills and the autonomy of the team.
• Quality Management System Process Ownership
  • Ensure consistency and the maintenance of the quality management system.
  • Ensure that the Quality system complies with customer requirements, internal rules, regulatory requirements and GMPs.
  • Consider deviations identified during audits/inspections and implement corrective actions.
  • Present the results of the Quality Management Process periodically and suggest areas for improvement.
  • Update the quality manual in line with changes in the quality system.
  • Coordinate with other departments the appropriate site housekeeping thanks to internal audits, including regular site visits.
  • Ensure preliminary preparation of the audit.
  • Be a Front Room Leader during customer audits, and regulatory inspections if needed.
  • Respond as SME to inquiries relating to your department and areas of responsibilities the day of audit.
  • Propose improvement, lead or participate in site, quality or other improvements.
• Quality Systems Processes Management. Change Control Management.
  • Oversee the change management process.
  • Lead the change control committee and reach appropriate consensus with the stakeholders (content, deadlines)
  • Ensure compliance with the change management procedure.
  • Monitor actions items and ensure the closure of action items on time.
• Changes Approved CAPA, Actions Items Management
  • Ensure the implementation on time of action after deviations, complaints, and recurrences.
  • Approve the consistency and the effectiveness of all action plans.
  • Ensure closure of action plans.
• Deviations Management
  • Analyze the recurrent causes of failures and lead the periodic recurrence committee.
  • Lead or participate to the trouble shooting teams, define an appropriate action plan with the departments concerned, and propose areas for improvement.
  • Manage and take in charge of investigations into recurring issues identified following recurrence meetings.
• Self-Inspection and Internal Audit Management
  • Formalize the audit schedule for year based on the risk approach, justifying the priorities.
  • Ensure the follow-up of the schedule and justify any deviations.
  • Support the auditors in the preparation of the audit, the classification of deviations, the development of responses and the implementation of actions.
  • Ensure the continued training of the internal audit team.
• Risk Management (Product and Systems) and Annual Product Review Management
  • Formalize a schedule for the year and ensure the completion of APRs in accordance with it.
  • Formalize a risk assessment schedule and ensure the completion of it.
  • Collect, analyze, and discuss the data on a formalized report. Identify if needed the appropriate action plan.
  • Ensure that the content complies with applicable standards and is part of the Site's quality policy.
• Quality Software Administration (EnnovDoc and Track Wise)
  • Manage upgrades and changes and keep system documentation up to date. Participate to the validation if needed.
  • Create accounts for new arrivals and modify accounts when changes are made.
  • Perform the setting in accordance with applicable procedure requirements.
  • Oversee the resolution of user issues and concerns.
  • Dispense quality software training.
• Documentation System Management
  • Ensure paper and electronic diffusion of documents.
  • Ensure document modifications as document administration
  • Participate to the updating of documents to support operational staff in
  • Ensure paper and electronic distribution of documents.
  • Ensure document modifications as document issue
  • Monitor document awareness among all users.
  • Update documents to support operational staff in certain contexts such as projects, CAPA or changes control.
  • Oversee the archives management for the site.
  • Ensure the destruction of the expired documents according to the standards in place.
• Suppliers' Management
  • Ensure and maintain the supplier's qualifications of raw materials, primary and secondary packaging components and subcontractors and services involved in pharmaceutical operations.
  • Define the suppliers' management strategy, write, and maintain the procedures.
  • Propose a documentation structure to support the strategy.
  • Define the audit schedule based on a risk approach, define the costs for the year, and oversee the completion to the planning and the costs, or justify the variations.
  • Evaluate supplier quality audits reports and approve the actions plan proposed.
  • Participate to the approval of suppliers.
  • Control the entire supply chain for active ingredients, including the intermediate and distributors.
  • Maintain the Approved Supplier List.
  • Ensure appropriate management of supplier complaints and propose action plan.
  • Supplier Board meeting management: maintain the proper documentation (statement) and assess the changes.
• People Leadership & Talent Management Responsibilities
  • Provide direct leadership and oversight of assigned staff, including performance management, annual performance evaluations, ongoing coaching, mentoring, and goal setting.
  • Conduct regular managerial touchpoints with supervisors and team members to reinforce expectations, increase engagement, and support individual and team development.
  • Partner with Human Resources to support workforce planning, staffing needs, interviewing, and selection of qualified candidates.
  • Actively participate in succession planning and organizational development initiatives, identifying high-potential talent and development opportunities within the manufacturing organization.
  • Support onboarding, training, and ongoing development to ensure employees are equipped to meet operational, quality, and compliance expectations.
  • Demonstrate flexibility and responsiveness to meet evolving business needs and HR-driven initiatives, including staffing adjustments, talent reviews, engagement efforts, and change management activities.
  • Foster a culture of accountability, inclusion, engagement, and continuous improvement through consistent leadership presence and communication.

We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.