Johnson & Johnson Careers
Senior Manager QA API
Requisition ID: 1805706122W
- Maintain and improve the Quality Management System, its documentation, deployment, management review and evaluate its performance.
- Drive a culture of proactive quality and continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.
- Conduct research, collect data, analyze trends and risks and ensure preparation of reports for assigned Quality processes.
- Follow up on management indicators and results.
- Ensure management and closure of non-conformance records, change control records and corrective / preventive actions.
- Guide, train, evaluate and develop the personnel in charge.
- Provide guidance and direction on Quality issues to different areas.
- Escalation Lead for significant Quality issues
- Provide information analysis and guidance to site and JSC management in projects with GxP impact, ensuring adequate communication of needs and quality status & compliance to all areas affected.
- Act as an expert in quality and compliance in the inter-functional groups of the company.
- Authorize documentation related to GxP processes.
- Ensure that the Business unit is ready to receive audits or GxP inspections.
- Lead audits and GxP inspections
- Evaluate the results of management reviews, audits, etc., and govern the implementation of corrective actions.
- Evaluate quality performance indicators and lead the implementation of the actions required for continuous improvement.
- Prepare and manage the budget of the area ensuring good control and use of resources.
- Coordinate GxP trainings for the quality assurance group, including new employees.
- Provide guidance and training to quality personnel according to the company's organizational and policy objectives.
- Encourage and support the development of area staff through the definition of challenging objectives, follow-up of action plans and training opportunities.
- Ensure alignment and benchmarking with other JSC manufacturing sites
- Assignment of tasks and delegation of responsibilities to the group, in accordance with the provisions of the work plan and the needs of the area.
- Determine the needs for the elaboration of procedures related to the activities of the area.
- Preparation/approvals of reports and tasks generated in the area
- Resolution of non-conformities that put at risk the quality of a product or the customer.
- Establishment of Strategies in the area.
- Authorization of the annual work plan.
- Authorization of strategies for the implementation of new regulatory, regional or corporate requirements.
- Request for material and human resources for the area.
Managers and / or area supervisorsDirectors and / or Quality Managers of J&J affiliates, Q&C functions and external customers
- Keep them informed on relevant quality issues and to effectively and timely disclose changes or new corporate or regional regulatory requirements regarding Good Manufacturing Practices issued by Health Authorities or by Johnson & Johnson
- all activities involved with quality assurance
- Quality and compliance issues of the products manufactured, as well as action plans to mitigate or avoid risks associated with the quality of the product and other activities involved with quality assurance
- A minimum of a Bachelor’s degree is required with a major or concentration in one of the following: Chemistry, Pharmacy, Biochemistry, Engineering, or a similar technical/scientific degree. A Master’s degree or advanced is desirable.
- Minimum 5 years in a leadership role within a API or Drug Product supply chain in Operations or Quality Operations.
- Strong understanding of manufacturing, analytics, quality, compliance and knowledge of local & global regulatory requirements
- Experienced in leading and coordinating regulatory inspections and customer audits
- Ability to operate in a global matrix organization with multiple stakeholders
- Excellent communication skills, verbal and written in both English and German
- Flexible, motivated and solution oriented team player
- In-depth knowledge in GMP standards, policies and procedures
- Strong decision making and problem solving competencies
- Knowledge of administration and personnel management.
- Sound knowledge about implementation and optimization of quality systems and processes
- Knowledge of statistics and process excellence tools
- Ability to influence and negotiate across the organization at all levels.
- Leadership imperatives
- Connect with Business Partners, Stakeholders and Customers
- Shape: shape changes to support continues improvement
- Lead: create an environment in which the quality and compliance culture is considered the key for success (right to sell)
- Deliver: Deliver results by inspiring and mobilizing people and cross functional teams
We are offering you a challenge in a dynamic, international environment with attractive terms and career opportunities.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
Cilag AG (8562)