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

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Quality Systems/ Quality Engineering Manager

Responsible for the management of the Quality Systems and MO lab staff to ensure optimal QA support to the Operations and NPI Organizations.

Drive compliance improvements and ensure applicable site, division, corporate and external compliance requirements are met. Provides policy input to site quality head function. Selects trains and develops key staff to ensure availability of resources to support the QMS and NPI test objectives. Advises and supports decisions on significant quality and products issues. Manages allocated budget against approved plan. Participates as a member of the on- site QA management team.

Drive and define functional strategies for the MO Lab. Creates and manages complex testing techniques and/or instruments in the delivery of business results and provides project leadership within the MO Lab. Analyzes complex issues and significantly improves, changes, and/or adapts projects or programs. Develops solutions that require extensive analysis and detailed investigations. Receives occasional, summary instructions from Quality leaders at various levels, in addition to other stakeholders.

Observes and promotes all regulatory compliance (QSR, ISO) policies, and rules and procedures, established by the Company.

duties & responsibilities

As Manager in general:

• Supervises the personnel and deployment of the Quality System within the primary areas of responsibility to ensure compliance and to support the effectiveness and efficiency of the quality systems to ensure continuity of the manufacturing process
• Serves as Quality Assurance/ SME for Quality Management Systems and MO Laboratory
• Identifies, prioritizes, and executes quality and cost improvement projects that support business goals by benchmarking and using best practices. Develops, and maintains, internal and external partnerships to increase understanding of other functional areas.
• Maintains staff by recruiting, selecting, orienting and training employees and developing personal growth opportunities. Ensures that all direct personnel are properly trained to perform their assigned functions in accordance with applicable procedures.
• Manages Co-ordination with staff members and other departments to ensure that targets / goals are achieved.
• Identify, analyze, document and as appropriate escalate issues to site Quality head function
• Ensure that quality awareness is improved in the organization by ensuring training of cross functional employees on quality management system procedures and processes

For Quality Systems:

• Develop and maintain quality management system documentation / change control system and documentation archive. Manages the Document Control area to develop and implement tools and best practices to encourage an environment for sharing and preserving records and information that are reliable, trustworthy, and complete; and promotes and implements record and information keeping practices that meet the legal, regulatory, business, and operational requirements. Responsible for ensuring documents submitted with changes conform to established standards. Provides support to contributors of the change control process.
• Monitor and evaluate the effectiveness of the quality management systems
• Leads and supervises Corrective and preventive actions (CAPA) program.
• Lead preparation for external audits including (co)hosting audit streams. Review of internal and supplier audits.
• Manages the training function to develop and implement training programs that support company objectives. Keeps abreast of training and development research, new materials, methods and techniques.
• Monitors trends, identifies issues, recommends, and implements appropriate actions for alignment to business strategy. Leads preparation of Data Review Board/ Management Review

For MO lab:

• Create/maintain Test capabilities and equipment at MO lab for marketed product (Test methods and execution of Incoming Inspection or release testing, additional testing to support nonconformance process or manufacturing engineering testing)
• Provide Quality assurance support of product/process development/improvement projects (Test capabilities/equipment at MO lab, support with transfer of Test methods from NPI to Operations)
• Execution and review of statistical analysis supporting the implementation of statistical process control, sampling and other quality tools for the MO lab.
• The generation and review of qualification and validation protocols and reports for the MO lab.
• Manage budget to maintain/purchase new equipment to support the business needs

experience & education

• Bachelor’s Degree or equivalent.
• 6-8 years of experience in Quality Engineering or Quality Assurance functions within the Pharmaceutical or Medical Device Industry is required.
• 2-4 years in supervisory experience.
• Experience dealing with applicable Health Authority inspections.

required knowledge, skills, abilities, certifications/licenses and affiliations

• Excellent organizational, interpersonal, written and oral communication skills in English.
• Thorough knowledge of FDA and International Regulatory requirements.
• Ability to build partnerships both internally and externally. Ability to effectively interface with governmental and independent auditors.
• In-depth working knowledge of quality systems and laboratory testing processes
• Proven success in the execution and application of quality systems, including the application of statistical principles and development of test methods .
• Proven leadership and problem-solving skills.
• Demonstrated ability to effectively present information to top management and public groups.
• Ability to prioritize and handle multiple tasks, and to facilitate and resolve cross functional activities and issues.
• High tolerance for ambiguity in a complex environment. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

location

Groningen, The Netherlands