Senior Executive, Business Quality
Functions: Quality Assurance
Requisition ID: 1805691552W
One Johnson & Johnson (J&J) is a provider of consumer, pharmaceutical and medical devices and diagnostics products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal, cure disease and improve the quality of life of patients and consumers.
Contribute to maintenance, compliance and improvement of the Quality Management System in accordance with J&J Quality Policy and associated enterprise and/or sector standards throughout the organization in accordance with current Good Distribution Practices for Pharmaceutical requirements and corporate policies as well as local Health Authority regulations
Participate in conducting audits – internal, external such as local distributor/service provider audits and associated activity and communication
Liaise with auditors during inspection activities and contributing to post-audit execution of corrective action and preventive action
Coordinate the product complaint process and field actions, liaising with regulators, sales and marketing, field sales engineers, customer service and warehouse personnel as appropriate, to ensure all activities are executed accordingly and within the stipulated timeframes
Coordinate activities related to CAPA, Non-conformance, change control, risk assessment and other applicable quality activities as specified in the appropriate procedures.
Conduct training related to QMS and corporate policies for new employees
Work with cross-functional team to accomplish change control closure in a timely manner according to established timelines
Assigned to special projects as needed and collaborate to improve quality system compliance if required
Bachelor’s degree or equivalent in Science, Pharmacy or related discipline
Minimum 3 years of experience in the related field, preferred in medical device or pharmaceutical industry.
Experience across the elements of a quality organization – quality systems, regulatory, quality operations and regulatory compliance.
Familiarity with current Good Manufacturing Practice, the regulatory systems and product registration requirements in Singapore
Enthusiasm for Quality & Compliance and/or Regulatory Affairs: achievement oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment;
Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;
Ability to work with broad scope/different types of products in a fast-paced environment.
Ability to work in a matrix environment with multiple stakeholders and priorities and influence leadership.
Excellent verbal and written communication skills – proficiency in written and oral English is required