Director Quality Assurance Sassenheim

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Director Quality Assurance Sassenheim

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Essential Job Duties and Responsibilities

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. Manages a team of people leaders and technical professionals within the QA based on assigned work, direction, mentoring and developing capabilities. Develops and implements long-term strategies, and execution of Quality Programs.

We are seeking a dynamic and experienced Director, Quality Assurance to join our team in Sassenheim. In this pivotal role, you will be responsible for driving the Quality Assurance strategy for our site, ensuring that all quality standards are met and maintained throughout our operations. The ideal candidate will possess 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

• Develops, implements and drives a comprehensive Quality Assurance strategy, aligned with site goals.
• Leads the establishment and execution of quality objectives and key performance indicators (KPIs) that drive continuous improvement and operational excellence.
• Proactively identifies recurring trends and implements 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. Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
• Develops and champions an interpersonal culture that promotes behaviors that lead to outstanding business performance and organizational excellence.
• Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality-related risks.
• Responsible for appropriately staffing and developing the Quality Operations organization to meet budget and succession plans.
• Leads launches of new products and technologies. Participates in product stage gate reviews representing Raritan site Quality Assurance.
• Partners with the Compliance Team to prepare for and support Health Authority inspections at Raritan. Leads and hosts compliance audits. Serves 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.
• Ensures that all external customer complaints and internal complaints from affiliates are handled, evaluated and investigated in timely and effective manner, in conformance with cGMP’s, Janssen Supply Chain Policies and Procedures.

Contacts:

• Product Quality Management. Purpose: to ensure timely and accurately stability testing for AT products, including reporting, data interpretation, trending, quality investigation and escalation
• All GMP departments in the site (BU4 Biotherapeutics, BU5, BU2, MAM, MSAT, IT etc.). Purpose: To deliver the quality assurance and quality control services for the different departments and to request support where applicable for Quality Control activities.
• Third Parties/Contract Manufacturing sites and external quality: Purpose: to ensure timely and accurately release or stability testing, including reporting, data interpretation, trending, quality investigation and escalation
• J&J contacts: J&J Corporate Compliance, RA departments and other sister sites. Purpose: to ensure alignment with these sites in the areas of the department’s responsibility.
• Regulatory authorities and 3rd Parties. Purpose: ensure the regulatory expectations of the site’s inspection readiness are met and for an effective execution of regulatory/3rd Party inspections
• External service department and contract labs. Purpose: ensure external test executing and reporting and external service.
• Finance Management. Purpose: for budget management
• HR. Purpose: all aspects of people management

Minimum Qualification

• Master’s degree in scientific/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 required.
• Experience with implementing and coordinating GMP operations in a commercial facility.
• Significant experience in supporting functional area (e.g., R&D, Manufacturing, Engineering, EHS, or Technical Services) preferred.
• Experience & Interaction with FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. A thorough knowledge of GMPs is required. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• 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.

Other Requirements

• Balanced decision-maker.
• Knowledgeable of Quality Risk Management concepts/
• Ability to build and nurture strong and positive relationships.
• Team collaboration skills and coaching skills.
• 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.
• External relationships and visibility in the industry. Credibility with regulatory agencies (e.g., EMA and FDA) is critical.
• 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 the boundaries of 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.

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