Quality Systems Manager

Quality Systems Manager Who we are?

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible. We are a world leader in sterile single dose with 10 sites on 4 continents and more than 2400 employees. Since 2013, our Rochester, NY site, Unither Manufacturing LLC, specializes in the manufacture of Blow‑Fill‑Seal, Liquid Stick‑Packs, pharmaceutical bottles, tablets and capsules and employs more than 360 people.

Reporting to the Quality Director
, the Quality Systems Manager oversees the process and management of systems, deviation management, change control, risk, documentation, and supplier management. The role is the main contact for customer audits and regulatory inspections and is responsible for CAPA plan establishment and execution on time. The manager owns the Quality Management System, presents dashboards periodically, identifies improvement areas, and leads a team across multiple topics and timelines.

• Ensure the team's training is appropriate for executing the missions.
• Conduct annual interviews to assess team development and performance.
• Define priorities in handling resources and deadlines.
• Develop the skills and autonomy of the team.

• Ensure consistency and maintenance of the quality management system.
• Ensure compliance with customer requirements, internal rules, regulatory requirements and GMPs.
• Implement corrective actions for deviations identified during audits/inspections.
• Present QMS results periodically and suggest improvement areas.
• Update the quality manual in line with system changes.
• Coordinate housekeeping through internal audits and regular site visits.
• Prepare preliminary audit documentation.
• Act as Front Room Leader during customer audits and regulatory inspections.
• Respond as SME to inquiries on the day of audit.
• Propose or lead site, quality, or other improvement initiatives.

• Oversee the change management process.
• Lead the change control committee and reach consensus with stakeholders.
• Ensure compliance with the change management procedure.
• Monitor actions and ensure closure on time.
• Validate approved changes.

• Ensure timely implementation of actions following deviations, complaints, and recurrences.
• Approve the consistency and effectiveness of all action plans.
• Ensure closure of action plans.

• Analyze recurrent causes of failures and lead the periodic recurrence committee.
• Lead or participate in trouble‑shouting teams, define action plans with departments, and propose improvement areas.
• Manage investigations into recurring issues identified after recurrence meetings.

• Formalize the audit schedule for the year based on a risk approach.
• Ensure schedule follow‑up and justify deviations.
• Support auditors in preparation, deviation classification, response development, and action implementation.
• Ensure continued training of the internal audit team.

• Formalize and ensure completion of APRs in accordance with the schedule.
• Complete risk assessment schedules.
• Collect, analyze, and discuss data in a formal report and identify action plans.
• Ensure content complies with applicable standards and fits the Site’s quality policy.

• Manage upgrades, changes, and keep system documentation up to date; participate in validation if needed.
• Create and modify user accounts.
• Perform system configuration according to procedure requirements.
• Resolve user issues and concerns.
• Provide quality software training.

• Ensure paper and electronic dissemination of documents.
• Administrative modifications of documents.
• Update documents to support operational staff in projects, CAPA, or changes control.
• Monitor document awareness among all users.
• Oversee archive management.
• Ensure destruction of expired documents per standards.

• Maintain supplier…