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Manager Quality Systems
role at
Johnson & Johnson Innovative Medicine
.
About Johnson & Johnson Innovative Medicine
At Johnson & Johnson, we believe health is everything.
Our expertise in Innovative Medicine and MedTech empowers us to build a world where complex diseases are prevented, treated, and cured.
Through our science-based advancements, we innovate across the full spectrum of healthcare solutions to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Role Overview
This Manager Quality Systems position will lead the activities of the Quality Systems Department at Bio Cork J&J Innovative Medicine.
The role manages change control, non-conformance investigations, documentation management, quality agreements process, complaints system, global standards process and other related quality system elements.
Key Responsibilities
Staff and develop the Quality System organization to meet business needs and succession plans.
Provide leadership and direction to the Quality and Site Management Team to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behaviour model.
Partner with other IMSC Site Quality Heads to ensure harmonization and alignment with IMSC Quality Policies, Guidelines, Programs and Systems.
Lead the Quality Systems Management Review (QSMR) and site quality risk register.
Own the Site Quality Plan.
Act as an active member of the QA Operational Leadership Team and support the Quality Metrics Program.
Develop and champion an organizational culture that promotes behaviours that lead to superior business performance and organizational excellence.
Create a commitment to customer service.
Encourage, support and direct initiatives and programmes that lead to improved quality and regulatory compliance.
Manage and guide staff and those involved in quality system activities to achieve the best results.
Mentor and coach staff, and develop and implement training programmes to ensure professional and personal development of department personnel.
Interface professionally with other Business units and departments, as well as staff from other affiliates in fulfilling responsibilities.
Ensure all employees comply with all applicable IMSC and governmental regulations, policies and guidelines.
Key Competencies & Requirements
Degree required in a scientific or engineering discipline.
5-10 years' experience in a quality area (e.g. R&D, Operations, MAM, QC, MSAT).
Experience in a significant leadership position within the biological and/or pharmaceutical industry.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals; ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
Proven success in managing in a global organization.
Desired Skills
Analytical Reasoning
Analytics Dashboards
Collaboration
Compliance Management
Data Gathering & Analysis
Data Quality
Incident Management
Performance Measurement
Process Improvements
Quality Control (QC)
Quality Management Systems (QMS)
Quality Services
Quality Standards
Risk Management
Systems Analysis
Systems Integration
Tactical Planning
Technical Credibility
Application Process
1. Application review: we'll carefully review your CV to see how your skills and experience align with the role.
2. Short call: if there's a good match, you'll be invited to a short call with one of our recruitment team.
3. Updates: our recruitment team will keep you informed of the next steps.
4. Final steps: successful candidates will complete country-specific checks before starting the new role.
5. Completion survey: you'll be invited to provide feedback on the process.
Benefits & Compensation
We provide a competitive compensation and benefits package that can be tailored to what is valuable to you throughout different stages of life, including support for physical and mental wellbeing.
Location
Ringaskiddy, Cork, Ireland
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