Title
Sr Manager Quality Systems & Quality Excellence
Job Function
Quality
Job Sub Function
Quality Systems
Job Category
Professional
Job Location(s)
Beerse, Antwerp, Belgium
Job Description
The Sr Manager Quality Systems & Quality Excellence will lead and manage the Quality System & Quality Excellence associates, the GMP training and Document Management office, and the Narcotic Compliance department within the J&J Innovative Medicine Supply Chain Beerse & Olen Belgium organization. The role ensures compliance of quality processes and identifies continuous improvement opportunities. The manager will serve as a quality systems expert, standardize and centralize processes, conduct data analysis, and develop resolutions aligned with departmental capabilities. Responsibilities include reporting to the Site Quality Head and participating in the Quality Management team.
Education and Experience
* Master’s Degree in Life Science or Engineering with a minimum of 10 years in a healthcare products, or comparable industry, manufacturing or quality environment (or Bachelor’s degree with increased experience).
* In-depth knowledge of quality processes such as Event handling & CAPA management, Change control management, Risk Management, Training & Document management.
* Knowledge of pharmaceutical legislation, cGMP/GDP regulations and guidelines, ISO standards in the area of ownership (e.g., EU eudralex volume 4, 21 CFR Part 210/211/820, ISO 13485, China regulations).
* Exposure to external inspections by EMEA and FDA authorities.
* Strong analytical thinking, risk assessment, communication, managerial and leadership skills.
* Knowledge of Dutch is advantageous.
Responsibilities
* Integrate reporting and analytical tools into Quality Systems processes for real time decision making.
* Ensure services, processes, and facilities comply with internal best practices, QA standards, international standards, and government regulations, collaborating with operational departments.
* Maintain key performance monitoring systems, review quality data, transform audit and inspection data into actionable insights and recommendations, and prepare weekly and quarterly reports.
* Lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organization and quality performance.
* Represent Quality Systems and Quality Excellence on steering committees and task forces.
* Lead the Narcotics Compliance team to ensure physical and administrative flow of controlled substances complies with legal requirements.
* Integrate the J&J Credo and Leadership Imperatives into team goals and decision making, coaching and developing the team in achieving quality, business and personal objectives.
Required Skills
People Management, Quality Management Systems (QMS)
Preferred Skills
Analytical Reasoning, Analytics Dashboards, Compliance Management, Data Gathering and Analysis, Data Quality, Incident Management, Organizing, Performance Measurement, Quality Control (QC), Quality Services, Quality Standards, Risk Management, Standard Operating Procedure (SOP), System Integration, Systems Analysis, Tactical Planning, Technical Credibility
Pay Range
€96,000.00 - €165,025.00
Benefits
In addition to base pay, this role offers an annual bonus with a set target (% of pay) based on performance, vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health, service anniversary and recognition awards, and participation in several insurance plans. Further details may vary by location and are subject to change.
Inclusion Statement
Johnson & Johnson values diversity and is committed to providing an inclusive work environment.
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