Site Quality Compliance Governance Lead (RE-33912419)
40% Lead the Right First Time program* Ensure tracking, and progress of the different initiatives / CAPA Continuous Improvement defined as part of the RFT program * Ensure reporting to the Senior Management of the progress and escalade any issue (delay, resources, etc) if any
40% Lead Quality Risk Management program: * Support the deployment of the Risk Management global SOP on site, * Implement the Risk register in alignment with global expectations. * Ensure a tracking and progress of the current TOP 10 compliance risk plan, provide regular update to senior management and support the transfer into the Risk register .
20% Lead the Quality council meetings: * Ensure the preparation by guarantying the availability of all the slide decks, * Support the execution of the meetings and the redaction of the meeting minutes reports.
- At least 5 years of management experience in the following areas in the pharmaceutical industry: Quality assurance, CAPA, Change Control, Validation, understanding of the requirements for manufacturing, plant utilities, computer systems and project management.
- Knowledge of applicable local and international regulations and laws for biological products, such as FDA CFR, cGMP, EU GMP, MD, EU Directives and guidelines
- Familiar with Quality Risk Management principles
- Interacts with Site Quality Head, other quality site functions and plant functions such as Manufacturing, Engineering, Manufacturing Science, IT, Supply Chain
- Interacts with global Quality functions
- Frequent contacts with equivalent level managers and customer representatives concerning projects, operational decisions, scheduling requirements, or contractual clarifications. Conducts briefings and technical meetings for internal and external representatives
- Excellent time, organizational, critical thinking, as well as strong verbal and written communication, presentation and technical skills.
- Ability to work effectively with all levels of management and resolve problems in a timely manner * French and English (written and spoken) - mandatory * Experience in Project management.
- Must be able to deal with ambiguity
- Has authority to make personnel and organizational decisions to ensure progress of the different programs under the scope of the mission