Requisition ID: 1805655544W
Manager Quality Systems & Compliance
Quality organization Janssen Biologics B.V. Leiden
The manager QSC is responsible for directing the Quality Systems & Compliance systems at the Janssen Bio site, in addition to the management of programs/ projects to ensure the achievement of planned quality objectives of the QSC department. Implements the QSC systems to ensure compliance to Janssen and JBV policies and procedures and to all applicable regulations. Selects, trains, motivates and develops key staff to ensure availability of resources to support the QSC objectives. Is responsible for the management of external agency audits on site. Participates as a member of the Quality management team of the JBV site.
We are looking for a Manager QSC that:
- Manages, leads & motivates the Quality Systems & Compliance department and its people to enhance performance and achieve business goals, agreed metrics & budget.
- Develops, improves and monitors comprehensive cGMP compliant Quality core systems to facilitate the production of high quality products to prevent or reduce the risk of defective products entering the marketplace.
- Acts as a knowledge center for Compliance subjects and ensures that JBV site is aware and executes according to the latest JNJ & cGMP regulations.
- Manages the resolution of unexpected complex compliance or quality system issues as they arise.
- Influences and manages regulatory and corporate expectations and relationships to ensure harmonization & alignment of the site’s core quality systems, plans and programs to maintain cGMP compliance in current and future situation.
- Is responsible for site’s Management Review program including the Quality Metrics programs, to ensure and proactively enhance compliance and business performance of the site.
- Manages inspection readiness programs, and hosts & manages the process during Quality Regulatory inspections, audits by partners and headquarters as well as coordination of observations responses and monitoring the follow-up actions across the site.
- Ensures that the internal audit program, including the service providers audit program, as well GMP training programs is conducted to ensure GMP compliance across the site in compliance with regulations and business expectations.
- Manages the development, implementation, and monitoring the effectiveness of cGMP Documentation processes and administration, to ensure that appropriate documentation practices are maintained at the site in compliance with regulations and business expectations.
- Manages the user input, implementation, and monitors the effectiveness of electronic Quality Systems, to ensure Data Integrity.
Qualifications and Competences:
- University degree in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry or process technology.
- Knowledge of current Quality Management principles, cGMP and Quality Systems Pharma regulations.
- 10 years’ experience in Quality of which 5 years in a managerial, people leading role.
- Significant experience interacting with various health authorities (e.g. FDA, EMA).
- Perfect writing and oral communication skills in English.
Janssen Biologics (7266)Job Function