Sr Mgr Quality Systems

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job 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 .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us

throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Sr Manager Quality Systems & Quality excellence

You will be leading and managing the Quality System & Quality excellence associates the GMP training and Document management office and the Narcotic Compliance department. You and your team will manage the different quality processes within the J&J Innovative Medicine Supply Chain Beerse & Olen Belgium organization in order to ensure compliance within each of these processes and to identify areas for continuous improvement. Your team will serve as Quality Systems expert and facilitates the standardization and centralization of processes and procedures through metrics reporting conducting data analysis on organizational quality issues and developing resolutions that align with department capabilities. You summarize quality data and prepare reports for improved organizational outcomes. You will report to the Site Quality head and be part of the Quality Management team.

Education and Experience

• Masters Degree in Life Science or Engineering with a minimum of 10 years preferably in a healthcare products or comparable industry manufacturing or quality environment. (or Bachelors degree with increased experience required).

• Thorough Knowledge of the different quality processes (such as Event handling & CAPA management Change control management Risk Management Training & Document management etc)

• Thorough knowledge of pharmaceutical legislation cGMP/GDP regulations and guidelines ISO standards in the area of ownership (ex: EU eudralex volume 4 21 CFR Part 210/211/820 ISO 13485 China regulations.)

• Have been exposed to external inspection by EMEA and FDA authorities.

• Strong analytical thinking risk assessment communication managerial and leadership skills.

• Knowledge of Dutch is advantageous

Responsibilities

• You integrate reporting and analytical tools into Quality Systems processes to enable real-time decision making.

• You ensure services processes and facilities are in line with internal best practices and in compliance with the organizational Quality Assurance (QA) standards international standards and government regulations through collaboration with the operational departments.

• You maintain key performance monitoring systems and reviews quality data from multiple areas of the organization. You transform data from audits and quality inspections into actionable insights and recommendations. You prepare weekly and quarterly reports on quality projects and tracks quality issues through dashboards. You serve as a liaison to the Data Analytics team and interprets information on quality issues.

• You will continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organisation and quality performance.

• You represent Quality Systems and Quality Excellence on different forms steering committees and task forces.

• You will lead the Narcotics Compliance team and you ensure the physical and administrative flow of controlled substances at Janssen Pharmaceutica Belgium is in compliance with the legal requirements on controlled substances .

• You will lead the Narcotics Compliance team and you ensure the physical and administrative flow of controlled substances at Janssen Pharmaceutica Belgium is in compliance with the legal requirements on controlled substances .

• You Integrate Johnson & Johnsons Credo and Leadership Imperatives into team goals and decision making. You manage coach and develop the team in reaching their quality business and personal objectives.

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.