Job Function: Quality
Job Sub Function: Quality Assurance
Job Category: People Leader
All Job Posting Locations: Sassenheim, Netherlands
Sr Manager QA Operations SSH LVVEssential Job Duties and Responsibilities
The Senior Manager Quality Assurance leads the team that ensures that the JBV quality systems are applied as per GMP standards within Janssen Biologics. QA Operations in Sassenheim supports the manufacturing of Lentiviral vector (LVV) products and delivers quality oversight for the AT QC laboratories. Close collaboration with the production department and the QC Laboratory is required. Functions and activities within the department comprise the full spectrum of Quality processes (e.g. Batch Record Review, Product Release, Changes, Non‑Conformances, CAPAs and complaint handling, Process and Cleaning validation, etc). There is a special focus on the institution of shop floor QA for aseptic manufacturing.
We are seeking a dynamic Senior Manager Quality Assurance to join our team in Sassenheim. In this pivotal role, the individual will be responsible for day‑to‑day Quality Assurance operations for the site, ensuring that all quality standards are met and maintained throughout our operations. The ideal candidate will possess strong leadership skills, extensive experience building and leading Quality teams, a deep understanding of quality management systems, aseptic manufacturing requirements, and a commitment to excellence in delivering safe and effective therapies to patients.
Principal responsibilities- Manages, leads & motivates the QA Operations SSH LVV department and its people to enhance performance and achieve business goals, agreed metrics & budgets
- Leads the Quality team responsible for batch release and QP disposition of the commercial products manufactured at the site
- Manages and improves the GMP processes to facilitate the production and testing of commercial products at JBV (e.g JJOS)
- Manages the resolution of unexpected complex quality or compliance issues across the whole site (where needed)
- Influences and manages regulatory and corporate expectations and relationships to ensure alignment of the site’s quality systems, projects and programs to maintain GMP compliance, with special focus on commercial product manufacturing and compliance
- Supports or leads (global) escalations of issues, which have (potential) impact on the delivery of commercial products
- Replaces other QA MT members, and the SQH when needed
- Participates in quality and capacity projects, and acts as SME on Quality topics
- Supports inspection readiness programs and regulatory inspections
- Collaborates with all site operational and support departments to ensure quality oversight on the commercial manufacturing and testing activities in these departments and to ensure execution is in line with the regulations and company’s policies and guidelines
- Collaborates and ensures alignment with J&J Corporate Compliance, RA departments and other sites within the J&J network
- University degree at a master level in a relevant discipline, e.g. Biosciences, pharmacy, analytical chemistry, process technology or engineering
- Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations
- Minimum 10 years’ experience in Quality, of which 5‑7 years in a managerial, people‑leading role
- Deep understanding and application of Global Regulatory (cGMP/ICH/FDA/EMA) Guidelines in an Operations environment
- Knowledge of/and experience in development of Quality Systems and Processes
- Perfect written and oral communication skills in Dutch and English
- Team player, and ready to take a stand when necessary
- Excellent written and verbal communication skills with an open, collaborative, interactive leadership style
- Balanced decision‑maker
- Ability to build and nurture strong and positive relationships
- The ability to work in a team environment and interact with all levels of the organization
- Results‑driven leader who commits to stretch goals and delivers results
- An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements
The anticipated base pay range for this position is 80.800 Euro to 140.530 Euro on an annual basis and includes 8% holiday allowance.
Required Skills:- Compliance Management
- Corrective and Preventive Action (CAPA)
- Cross‑Functional Collaboration
- Developing Others
- Fact‑Based Decision Making
- Give Feedback
- Good Manufacturing Practices (GMP)
- Inclusive Leadership
- ISO 9001
- Leadership
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Quality Validation
- Risk Assessments
- Standard Operating Procedure (SOP)
- Tactical Thinking
- Team Management
- Compliance Management
- Corrective and Preventive Action (CAPA)
- Cross‑Functional Collaboration
- Developing Others
- Fact‑Based Decision Making
- Give Feedback
- Good Manufacturing Practices (GMP)
- Inclusive Leadership
- ISO 9001
- Leadership
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Quality Validation
- Risk Assessments
- Standard Operating Procedure (SOP)
- Tactical Thinking
- Team Management
€80800 - €140530 monthly