Director Quality Assurance Sassenheim
Posted 2 days ago by Johnson & Johnson Innovative Medicine
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Job Function: Quality
Job Sub Function: Quality Assurance
Job Category: Professional
Location: Sassenheim, Netherlands
The Director, Quality Assurance Sassenheim leads and handles all aspects of Quality Assurance in support of the local site Advanced Therapies activities, in full compliance with established cGMP, J&J and JSC requirements. Functions and activities include quality oversight of incoming materials, QA shop floor, batch record review, drug substance (lentivirus) release and production, and QC facilities. The Director manages a team of people leaders and technical professionals within the QA based on assigned work, direction, mentoring and development of capabilities. They develop and implement long term strategies and execute quality programs.
We are seeking a dynamic and experienced Director of Quality Assurance to join our team in Sassenheim. In this pivotal role, you will drive the Quality Assurance strategy for our site, ensuring that all quality standards are met and maintained throughout our operations. The ideal candidate possesses strong leadership skills, 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- Develop, implement and drive a comprehensive Quality Assurance strategy, aligned with site goals.
- Lead the establishment and execution of quality objectives and key performance indicators (KPIs) that drive continuous improvement and operational excellence.
- Proactively identify recurring trends and implement a Right First Time program in collaboration with manufacturing and QC operations to reduce deviations and improve efficiency.
- Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality related risks.
- Provide leadership and direction to the Quality and Site Management Teams to meet business, quality and compliance goals following the J&J Standard of Leadership behavior model.
- Develop and champion an interpersonal culture that promotes outstanding business performance and organizational excellence.
- Responsible for appropriately staffing and developing the Quality Operations organization to meet budget and succession plans.
- Lead launches of new products and technologies and participate in product stage gate reviews representing the Raritan site Quality Assurance.
- Partner with the Compliance Team to prepare for and support Health Authority inspections at Raritan. Lead and host compliance audits.
- Serve as SME for QA operations to support all regulatory inspections.
- Lead initiatives focused on process optimization, data driven decision making, and the application of quality improvement methodologies (e.g., Six Sigma, Lean).
- Monitor industry trends and emerging best practices to innovate and enhance quality processes within the organization.
- Ensure that all external customer complaints and internal complaints from affiliates are handled, evaluated and investigated in a timely and effective manner, in conformance with cGMP, Janssen Supply Chain Policies and Procedures.
- Product Quality Management - ensure timely and accurate stability testing for AT products, including reporting, data interpretation, trending, quality investigation and escalation.
- All GMP departments in the site - deliver the quality assurance and quality control services for the different departments.
- Third party/Contract Manufacturing sites and external quality - ensure timely release or stability testing.
- J&J Corporate Compliance, RA departments and sister sites - ensure alignment with departmental responsibilities.
- Regulatory authorities and third parties - ensure regulatory expectations of inspection readiness are met.
- External service department and contract labs - ensure external test execution and reporting.
- Finance Management - budget management.
- HR - all aspects of people management.
- Master's degree in a scientific or technical discipline with 10-15 years' experience in a significant leadership position within the biological and/or pharmaceutical industry.
- 5-7 years' experience in a Quality leadership role.
- Experience with implementing and coordinating GMP operations in a commercial facility.
- Significant experience in supporting functional areas (e.g., R&D, Manufacturing, Engineering, EHS, or Technical Services) preferred.
- Experience and interaction with FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Knowledge of GMPs and ability to apply FDA and international guidelines.
- Excellent written and verbal communication skills with an open, collaborative, interactive leadership style.
- Demonstrated strategic thinking capabilities and the ability to help define a vision for the future.
- Balanced decision maker.
- Knowledgeable of Quality Risk Management concepts.
- Ability to build and nurture strong and positive relationships.
- Team collaboration and coaching skills.
- Results driven leader who commits to stretch goals and delivers results.
- External relationships and visibility in the industry; credibility with regulatory agencies (EMA, FDA).
- Ability to translate strategy to execution and drive the organization forward in executing and delivering results.
- An unquestionable level of integrity and commitment to operating ethically and within regulatory requirements.
The anticipated base pay range for this position is 99,000 Euro to 171,350 Euro on an annual basis and includes 8% holiday allowance.
Required Skills- Business Alignment
- Collaborating
- Compliance Management
- Fact Based Decision Making
- Good Manufacturing Practices (GMP)
- ISO 9001
- Mentorship
- Quality Auditing
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Quality Validation
- Regulatory Environment
- Standard Operating Procedure (SOP)
- Tactical Planning
- Tactical Thinking
- Technical Credibility