Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
This position within Celgene Global Quality Operations and Celgene Affiliates Quality is responsible for the development, implementation and maintenance of Quality Management Systems, including the documentation and training management for the Celgene Affiliates, across the Central Eastern European (CEE) region.
The position holder will be a member of the CEE Leadership Team and provide leadership to regional GMP / GDP quality responsible functions across Poland, Czech Republic, Hungary, Slovakia, Slovenia and Croatia.
The position will be expected to be a reliable source of information, having established knowledge of quality assurance and GMP / GDP compliance requirements in the CEE region.
Expectation is to build strong, collaborative relationships with all stakeholders, ensuring the highest levels of pharmaceutical quality for distribution of Celgene products.
The position holder will work closely together with the Quality Systems teams of Celgene Global GMP / GDP Compliance function and may get project assignments from the Director, Affiliates Quality, for quality improvement initiatives.
Role and Responsibilities
Provide guidance, support, oversight and framework for local ownership of the Quality Management Systems at the respective affiliates of the CEE region.
Provides quality oversight at the Celgene affiliate offices in accordance with Celgene policies, standards, procedures for GMPs and GDPs.
Contribute to the improvement of existing processes and the development of new processes or sub-processes related to the QMS across the CEE region.
Align Quality Systems strategies with the Global Quality Systems by harmonizing common concepts, assisting to SOP writing and by making recommendations for SOP revisions as applicable in the CEE region.
Maintains high compliance primarily in GMP / GDP trainings but also with other technically-related functions depending on the affiliate requirements.
Conduct face to face GMP / GDP trainings for affiliate quality personnel across the CEE region, upon demand from the Affiliates within the region.
Define training Curricula and is responsible for maintaining the training documentation and oversight of onboarding new personnel at the respective affiliates within CEE region.
Maintain local system administrator role for DMS and LMS and assess potential impact of any changes on Global system on the Regional / Local (affiliate) Quality Systems.
Supports the Director, Affiliates Quality, in the development, implementation, continuous improvement and harmonization of Quality Management Systems across Celgene Global affiliates.
Provide support to quality responsible functions of Affiliates within CEE region. for Compliance systems and processes (Deviations, CAPA, Change Control, Product Quality Complaints handling, Product returns, Risk Management) in coordination with the respective QA Logistics and other Global functions.
Ensure that the Distributor’s quality management and compliance systems that have been implemented are adequate for the distributor’s activities and are maintained.
Participate in CEE hub leadership meetings as the Quality representative.
Participate in existing review meetings for the Global Affiliates as organized by the Director, Affiliates Quality.
Provide support to Director, Affiliates Quality for the organizing and / or coordinating periodic Affiliate Quality review meetings for Global Affiliates.
Participate in establishing and providing quality system metrics and key performance indicators for the affiliates (countries) within the CEE region in association with Celgene Global Quality Operations, with escalation to management level as appropriate.
Support establishing new Affiliates in the region and implementing quality related actions resulting from feedback and / or quality surveys of the existing Affiliates.
Support reviews and updates to Quality Agreements.
May co-host or provide support to CEE Affiliates during internal GMP / GDP (GxP) audits and / or Health Authority inspections, including the preparation and the execution thereof.
Gives guidance and support for defining CAPA action plans related to audit observations and / or Inspection findings as appropriate, and the subsequent follow up of said actions.
Deputy Role and activities
Represents Quality Management on CEE Hub on Regional initiatives and associated meetings, including Leadership Team Meetings.
Reviews and approves any (potential) changes and / or deviations follow up as Area Manager, in lieu of the Local Quality Management / QRP, and escalates to Global function as required.
Represents and act as deputy of the Director, Affiliates Quality in Regional / Local Quality Systems initiatives and associated meetings for the respective affiliates.
Skills / Knowledge Required
BSc. or MSc. in science or pharmaceutical / medically related field.
Demonstrated working experience in a position related to Quality Management Systems (QMS) including good understanding of requirements for documentation and training management in GxP environment, at both strategic and at operational level.
Established knowledge of cGMPs, GDP and regional (CEE) regulatory requirements.
Excellent interpersonal, collaborative and organizational skills.
Solution orientated with an ability to lead teams and influence at all levels.
Ability to work independently, yet effectively in a team environment.
Strong sense of partnership with systems users, ability to advise and give proactive support, with good understanding of internal customer needs.
High credibility and reliability, with strong sense of commitment.
Excellent written & oral communication skills in English; good working knowledge of local language may be an advantage
Ability to focus attention to details, strong commitment to quality and patient safety.
Expertise or experience of interacting with competent authorities / local health authorities is an advantage.
A professional qualification in quality auditing would be advantageous.