Sr. Director, Site Quality Head, Ghent Cell Therapy
Il y a 6 mois
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”
The CAR-T Quality department oversees all aspects of Quality (QA/QC), in support of the EU Advanced Therapies Supply Chain and manages Cell Therapy operations in Belgium including Obelisc and Techlane manufacturing facilities, and Beerse QC laboratories. Ensures compliance with established cGMP and J&J requirements.
**Role objective**:
The Sr. Director, Site Quality Head, Ghent Cell Therapy (CART) Operations leads and manages all aspects of Quality (QA/QC) in support of the Ghent CART manufacturing sites, in full compliance with established cGMP and JSC requirements. Functions and activities include Quality Control testing, Quality Assurance review and approval functions, validation (execution, review and approval) functions, Compliance activities, and Product Release activities. The role develops and implements long-term strategies, execution of Quality programs and manages a team of people leaders and technical professionals within the QA/QC departments based on assigned work, direction, coaching and developing capabilities.
**Main responsibilities**:
- Responsible for overall Quality oversight of cGMP operations (clinical and commercial manufacturing) at the Ghent Cell Therapy manufacturing facilities, and ensuring adherence to applicable GMP regulations and J&J policies and procedures
- As a member of the Advanced Therapies Quality Leadership team (ATQLT), partners with other JSC Site Quality Heads and partners to ensure harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems.
- Actively participates as a member of the Ghent Site Leadership Team, partners with the Site General Manager, Legend counterparts and CART Senior Leaders.
- Supports manufacturing network extension projects and ensures smooth knowledge transfer between internal and external nodes to ensure consistent deployment of standards and processes in design and operational phases.
- Assures the required processes, procedures, systems and resources are in place to ensure a compliant manufacturing, testing and distribution process.
- Collaborates with other leaders across the organization to assist in the continuous improvement and lifecycle management of GMP policies and the Quality Management System.
- Provides leadership and builds an exceptional team to manage the Quality functions, including hiring, mentoring and developing personnel
- Lead the site management review of Quality compliance and operational KPIs at the manufacturing facility; ensures timely mitigation of unfavorable trends
- Provides expertise and guidance in interpreting governmental/health authority regulations, agency guidelines and internal procedures to assure continued compliance
- Leads and hosts compliance audits including internal audits and regulatory inspections (e.g., FDA, IGJ, etc.). Proactively develops and sustains strong relationships with regulatory authorities.
- Analyzes regulatory authorities’ programs and activities in areas relevant to cell therapy products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
- Develop departmental goals and ensure timely completion of all deliverables
- Champion and fosters a positive quality compliance culture, and diverse and inclusive workplace
- Represents Ghent Cell Therapy Quality in the development, planning and execution of corporate initiatives
- Develops appropriate operating and capital expense budgets and strives to have the Quality organization contribute to turnaround time and COGS improvement.
- Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
- Manages team of senior leaders and professionals within Quality. Hires and develops employees within the department.
- Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
- Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectiv
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