Sr. Director, Sassenheim Quality Head & Global Lentivirus Operations

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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Job Description:

The Senior Director, Sassenheim Quality Head & Lentivirus Platform Owner, is a strategic leadership role responsible for overseeing all Quality (QA/QC) functions at the Johnson & Johnson Innovative Medicines Sassenheim site in Leiden, Netherlands. This role ensures strict compliance with cGMP standards and Janssen’s quality requirements, while establishing and maintaining robust Quality standards and systems across the site. The leader develops and executes long-term Quality strategies, driving a reliable supply of high-quality products for both clinical and commercial use through the J&J Supply Chain. Additionally, this role manages a team of QA & QC professionals, fostering a culture of excellence and continuous improvement. Beyond site-specific responsibilities, the role serves as the Quality partner to the Autologous Lentivirus Operations leader, focusing on compliantly expanding and scaling the global lentivirus supply chain across multiple locations in Raritan, Bern, and Sassenheim. This includes driving global consistency in Quality Operations and implementing structural and process changes to support scalable, compliant production.

You will be responsible for:

Sassenheim Site Quality Management Responsibilities

• Provides overarching leadership for cGMP operations (clinical and commercial) at the Sassenheim lentivirus cell therapy manufacturing facility, ensuring compliance with applicable regulations and J&J policies for CAR-T and lentiviral processes.

• Guides QA & QC teams to ensure the effectiveness of the Quality Management System (QMS) and GMP compliance across all manufacturing activities.

• Establishes and maintains a robust QMS aligned with Janssen’s quality objectives and regulatory standards.

• Participates in management reviews, evaluating process performance, product quality, and QMS effectiveness to foster continuous improvement.

• Ensures proper resource allocation, effective communication, and escalation of quality issues to senior management.

• Implements and maintains processes, procedures, and systems to support compliant manufacturing, testing, and distribution.

• Provides expertise on global health authority regulations, guiding interpretation and application to ensure ongoing compliance.

• Acts as the primary site representative during health authority inspections, leading internal and regulatory audits and fostering strong regulator relationships.

• Monitors and analyzes regulatory activities and guidance, advising leadership on potential impacts and opportunities.

• Oversees quality assurance programs to ensure all products are safe, effective, and compliant throughout their lifecycle.

• Develops and executes strategies for the Site Quality Organization, including QA, Quality Systems, and related functions, aligned with site goals.

• Serves as process owner for Product Quality Review and Management Review processes, establishing KPIs to monitor and improve operational performance.

• Ensures continuous training and development of quality personnel to meet evolving business and regulatory needs.

• Authorizes and maintains documentation, including SOPs and amendments, to ensure clarity and compliance.

• Approves and monitors suppliers, contract manufacturers, and outsourced GMP activities to uphold quality standards.

Delegation of Authority

• Acts as a deputy for the Qualified Person, with decision authority on product release, rejection of non-conforming products, and other quality-related matters, independently from management.

Global Lentivirus Operations

• Ensures consistent application of quality standards and practices across Bern, Raritan, and Sassenheim sites, promoting harmonization of processes, systems, and procedures.

• Drives the establishment and maintenance of standardized quality practices across the network, supporting global compliance and operational efficiency.

• Leads initiatives to identify and implement best practices, fostering continuous improvement in quality, efficiency, and reliability of lentivirus production.

• Promotes a “right first time” culture by proactively addressing process variances, streamlining workflows, and reducing deviations.

• Collaborates with site leaders and cross-functional teams to optimize supply chain access, expand manufacturing capacity, and ensure timely delivery of high-quality lentivirus products globally.

• Monitors performance metrics across sites, leveraging data-driven insights to drive improvements and ensure alignment with global quality standards.

Leadership Team Responsibilities

• Sets and manages targets and objectives for the Sassenheim site and the global lentivirus network, ensuring alignment with overall company strategy.

• Drives the achievement of annual goals, guided by Our Credo and leadership principles.

• Develops and manages operating and capital budgets, focusing on enhancing turnaround times and overall business performance.

• Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Technical Operations, Supply Chain, Product Development, key customers, and partners.

• Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes.

• Ensures the Quality department has a clear organizational structure, with robust formation and succession plans to support long-term stability.

• Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development.

• Champions a culture of quality compliance, diversity, inclusion, and continuous improvement.

• Assesses organizational strengths and areas for development, leading initiatives to enhance agility, efficiency, and effectiveness.

• Manages senior leaders and professionals within the Quality team, fostering ongoing talent development and succession planning.

• Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites.

• Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS.

• Represents Sassenheim in the planning, development, and execution of corporate Quality initiatives.

• Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes.

Required qualifications / Requirements:

• Education: University degree in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline.

• At least 12 years’ working experience in the pharmaceutical industry with demonstrated capability in quality leadership roles.

• Minimum of 12 years of Quality Assurance / Quality Systems experience related to manufacturing.

• Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems.

• Proven people management and Quality leadership experience.

• Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization.

• Comprehensive regulatory cGMP and technical knowledge to develop operational strategies necessary to maintain the desired level of inspection readiness.

• Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers.

• Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility.

• Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams.

• Extensive knowledge of chemical, biochemical and microbiological concepts.

• Knowledge of cGMP regulations and FDA/EU guidance.

• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred.

• Fluent in English and Dutch (written and spoken).

Skills:

• Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change.

• Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment.

• Ability to apply appropriate risk assessment strategies to manage business & compliance priorities.

• Effective negotiation and influencing skills and lead with a mindset of continuous improvement.

• Balanced decision-making skills and ability to effectively resolve conflict, when needed.

• Business acumen; develop and control budgets.

• Ability to communicate effectively with different levels in the organization and with health authorities.

Travel : Occasionally 25%

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The anticipated base pay range for this position is 127,900 EUR to 221,145 EUR on an annual basis and includes 8% holiday allowance.

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