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.

As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees.

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.

Your role

Reporting to the Quality Director,

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 aeras 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 (Ennov Doc 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.

*…