- Responsible for quality oversight of P&PD activities
- Establish Phase appropriate quality system for CLD, UPD, DSP, DPD and Pilot activities.
- Partners with the Quality organization to ensure P&PD activities adhere to the Quality Management System
- Continuously assesses compliance status of P&PD activities.
- Performs self-audits of the P&PD labs, systems, documents and provides support for client audits and health authority inspections as needed.
- Contribute as required to successful regular audits and any other interactions with regulatory agencies.
- Maintains strong relationships with multiple internal and external team members and cross functional groups.
- Creates and champions a Quality Culture where Quality is owned by all in an environment focused on continuous improvement and learning.
- Oversee/support/draft the development of SOPs for internal P&PD activities.
- Perform quality document review as required.
- Assist with or provide training for P&PD employees as appropriate.
- Oversee investigations of P&PD related quality issues, deviations, and root cause investigations.
- Conduct internal compliance metrics analyses and risk assessments related to functional area responsibilities and report to management as appropriate.
- Participate in establishing Data integrity controls for process development functions.
- Provide input to and support for Quality Management Review.
- Travel to JEB local and international sites as required.
- Master's degree in health sciences and 10 years of experience /or Ph.D. plus Minimum 5 years of experience.
- 5-10 years' experience in R&D quality or quality assurance background, in a regulated biotechnology or pharmaceutical industry.
- Knowledge of FDA, EMA and MHRA regulations and guidelines regarding GLP
- Excellent verbal and written communication skills.
- Knowledge of QMS and CAPA related processes and systems is required.
- Ability to work across functional areas and foster a collaborative culture of quality within the organization.
- Experience with NDA and/or BLA submissions
- Auditing experience: vendors (including labs), internal systems a plus.
- Candidates with experience in R&D Quality for biosimilars with specialization in assuring data integrity are preferred.
Process and Product Design Quality Compliance Manager - Toulouse, France - Evotec
Description
Process and Product Design Quality Compliance Manager
Permanent position
Just-Evotec Biologics is seeking P&PD Quality compliance manager to support our mission of advancing cost effective biotherapeutics manufacturing to provide access to all. The P&PD Quality Compliance Manager is a member of the Process and Product Design organization and is responsible for ensuring the highest product quality and data integrity for process development activities in alignment with quality expectations of applicable regulations, standards, and guidelines. The Manager works closely with P&PD staff to provide support, guidance and oversight of all scientific and technical activities that lead to data that may be submitted to a Health Authority (HA) in support of cell line, upstream, downstream, formulation and/or analytical development, as well as analytical process characterization and troubleshooting/root cause analysis for GMP activities. The Manager ensures that the P&PD organization adheres to accepted requirements for documentation, data integrity, record management, training, and facilities and equipment.
Responsibilities
Qualifications
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.