Sr. Director/Director, Quality Management Systems
Just-Evotec Biologics is seeking a highly motivated Sr. Director/Director, Quality Management System, that desires a significant opportunity to improve worldwide access to biotherapeutics. In this global role, the primary focus of this job is to build QMS to support a flexible clinical and commercial biotherapeutic operations at Just-Evotec Biologics state of the art J.POD manufacturing network.
The position is part of the Just-Evotec Biologics Quality Leadership team and will report directly to SVP, Quality. In this role, the successful candidate will lead a team of QA specialists and managers and:
- Develop, implement, and enable continuous improvement of the Quality Systems, which encompass but not limited to: QMS (Deviation, Change Control, CAPA), Documentation, Training, Supplier Management, Internal/Customer Audits and Customer Complaints.
- Ensure that Quality Systems are designed and operating in a way to provide appropriate support in all GxP areas of the company and are in compliance with current ICH and GMP standards (cGMP) both US FDA and EU.
- Develops, implements, and maintains corporate policy and procedures for the Quality Management System in accordance with ICH Q10 model
- Takes lead role in evaluating continuous improvement options for the Quality Systems post initial implementation
- Develops user requirements and contributes to the configuration, validation, implementation and lifecycle management of the electronic Quality Management System (eQMS)
- Establish department / individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics.
- Management of the site monthly Quality Management Review meeting. Facilitate creation of the presentation materials to include the Key Performance indicators, the meeting agenda and attendance, and to orchestrate the material presentation.
- Manage internal quality improvement initiatives: evaluate internal processes, suggest/design/implement improvements, create/revise relevant SOPs/Policies
- Acts as subject matter expert and provides training on all Quality Management Systems, including but not limited to change control, quality events, investigation and implementation of effective CAPAs
- Own and oversee the compilation of the Site Master File (SMF)
- Supports other members of the Quality Team and organization during its growth period in aspects not related to the core responsibilities of the Quality Systems area.
- Responsible for the coaching, training, and development of the Quality Systems team.
- Develop budget for department and ensures adherence to the budget.
- Drive continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
- BS, MS. in Biochemistry, Biology, Microbiology, Chemistry or a Scientific/Engineering degree
- 15+ years of in biotechnology or biopharmaceutical experience in a commercial manufacturing environment.
- Experience in QMS, QA and Manufacturing and/QC, experience dealing with Regulatory compliance. Experience in problem solving, process improvement, negotiations and supervision
- Strong management and leadership skills, including establishment of clear expectations and development of metrics and KPIs to monitor performance and ongoing activities
- Ability to deal with complexity, ambiguity, and multiple priorities simultaneously.
- Extensive experience and proven track record of success in installing and managing QMS
- In depth knowledge of 21 CFR 210, 21 CFR 211, ICH Q7, ICH Q9, ICH Q10, Eudralex – Volume 4, and Data Integrity and Compliance with cGMP and GAMP
- Deep understanding of biologics analytical GMP testing of clinical and commercial drug substance biological products, GMP raw materials inspection and release, and facility environmental monitoring programs
- Experienced in the use of electronic systems such as eQMS, LIMS, MES/EBR, and ERP systems
- Candidate must possess strong focus on attention to detail
- Possess effective task/time management organizational skills
- Good interpersonal, team, and communication skills are a must
- Ability to communicate effectively over teleconference and web-based meetings are necessary.
- Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)
Additional Preferred Qualifications:
- Entrepreneurial drive to achieve business objectives
- Knowledge and expertise to solve complex technical problems
- Active participation/lead technical projects with collaborators and vendors