Imagine your next project driving a shift from reactive to proactive quality management in a friendly, dynamic GMP facility where you can set new standards and influence commercial manufacturing expansion.This role is for a senior support individual contributor who executes non-routine tasks with limited supervision, guides other support team members, and conducts processes and activities supporting Quality requirements for the entire Operations unit. The employee is acquainted with annual company and division goals and aware of how they can influence these through performance. Demonstrating effective communication skills with internal and external customers, this position maintains high standards of professionalism, efficiency, personal communication, discretion, and independent judgment. The team consists of 14 specialists and 4 contractors, focusing on non-conformance flow, creating flawless process flows, and utilizing data analysis to resolve operational issues effectively. Start date is ASAP. Highlights of the opportunity include a dynamic environment with limited legacy history, providing the flexibility to shape how operations run.roles and responsibilitiesDemonstrates Johnson & Johnson’s Leadership Imperatives and Credo in day-to-day interactions with team.Is required to understand and comply with the Code of Business Conduct, Company policies and laws that govern their activities.Perform related duties as assigned by supervisor.Applies in-depth knowledge of Quality requirements to help execute organizational objectives.Perform nonconformance investigations, including CAPA records, lead change controls (CC) for the operations unit from initiation through completion.Drive cascade quality goals and guides non-routine complex cGMP problems and questions.Coach less experienced employees in the implementation of risk mitigations and continuous quality improvement projects for the entire Operations unit.Acts as Lead lysis, and reporting to ensure the continuous improvement of the quality standards.Ensure compliant documentation and timely completion of quality records.Initiate, drive, and lead cross-functional Operations unit quality improvements in close collaboration with stakeholders.Supports and reviews updating of procedures based on new or revised regulatory requirements, internal investigations, and audits.Helps conduct formal escalation processes to ensure visibility of risks associated with safety, product quality and regulatory compliance.Perform and direct comprehensive GEMBA walks to ensure full GMP compliance, drive continuous improvement initiatives.Takes ownership of personal training and ensures that all required training is understood and completed on time.Enhance a culture of belonging through trusting, diverse, & inclusive relationships.Guarantee that CAPA board documentation meets high-quality standards and is aligned with different stakeholders, ensuring uniformity for senior leaders.Supports the Subject Matter Expert on non-conformances and Change Controls during inspection and audits.Subject Matter Expert responsible for Change Control Assessments for general cGMP processes.Develops training programs for general cGMP processes.Formulate responses to observations from audits and inspections.Conducts data analysis on recurring non-conformances and recommends Corrective actions.how to succeedCandidates MUST have proven experience with leading change controls or non-conformances/quality investigations.A relevant HBO degree with 5 years relevant experience.English B2 language level is required.Intermediate level computer proficiency for MS Office, specialist level for data analysis (ability to get data and shape it), and analyst level for business applications.Positive attitude, proactivity, decisive, and organized with the ability to work independently and in a team.Maintain a high level of stress-resistance, ensuring calm and steady performance supporting team members in managing stress.High degree of accuracy and quality attitude.Flexible, can deal with changing priorities.Shows accountability by proactively addressing issues and taking responsibility for outcomes.Analytical thinking: ability ing questions, using data, using information, identifying gaps and root causes of issues, and thinking out of the box to develop a solution.Prioritize tasks of self and others effectively to meet deadlines and ensure timely delivery.Collaborates effectively with stakeholders and establishes meaningful connections with customers.Promote a culture of open communication, embrace feedback, and lead by example in continuous improvement and personal development.Lead team initiatives by providing clear direction and ensuring effective collaboration within the team.Articulate proposals to stakeholders, shaping the decision-making process and ensuring initiatives are framed within the business and departmental objective.benefitsThis role offers a very competitive hourly rate. This contract will initially run for 9 monthsyou are welcome hereJohnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.about Johnson & JohnsonCaring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part ategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.
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