Celgene Manager QA, Qualified Person in Utrecht, Netherlands
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.
BSc (or equivalent) in a technical or scientific discipline.
Extensive pharmaceutical (or other related industry) quality assurance/control experience (equivalent to a minimum of 5 years experience).
Expert level knowledge and application of GMP and GDP regulations
Including experience of Investigational Medicinal Products and Biological Products
The Manager, QA will report administratively and functionally to the QA Associate Director, QP
The primary role will be in developing, implementing and executing of Quality Systems and processes of Celgene within the Global Quality Organization to support the necessary licenses and which will ensure product quality and compliance with all regulatory and corporate requirements for Celgene Investigational Medicinal Products within Europe and Rest of World Markets as applicable.
Additionally, supporting in the implementation, organizing, managing, and execution of the Quality Assurance function and Quality Management System of Celgene Distribution BV which will ensure product quality and compliance of relevant manufacturing and distribution activities with all regulatory and corporate requirements for Celgene Commercial Products within EU/EEA and Rest of World Markets as applicable.
BSc (or equivalent) in a technical or scientific discipline which meets educational requirements as described in Article 49 2001/83/EC
Eligible to act as Qualified Person within EC/EEA for both investigational and commercial medicinal products
Extensive pharmaceutical quality assurance/control experience (equivalent to a minimum of 5 years experience), including audit, batch record review, change control, complaint handling and investigations experience
Must have proven strategic thinking and contingency planning skills
Must have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team oriented approach
Must have excellent organizational, project management and problem solving skills
Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly)
Must have experience and good knowledge of a variety of dosage forms ideally including solids, sterile and biological products and cell therapy products
Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance
Must have computer proficiency
Must have superior attention to detail
Duties and Responsibilities
Include, but are not limited to, the following:
Development and continuous improvement of quality systems and processes related to oversight and QP release of Investigational Products (IMPs)
Liase with internal and external contacts involved in manufacture and supply of IMPs (quality, supply, CMO QPs)
As required, act as IMP or commercial Qualified Person per requirements of Celgene licences, and in accordance with Professional Code of Conduct
Fulfill Qualified Person duties as defined in article 51 of 2001/83/EC
Ensure continued compliance, operationally, to site licences for Investigational Medicinal Products, Commercial Products and unlicensed medicines.
Interpret international, regional, and local regulations and apply those regulations within the GMP/GDP environment
Interact with executive level employees at third party contractors
Interact with Celgene Corporate and Celgene International functions as required by the tasks and responsibilities
To provide advice and guidance to regarding GMP and Qualified Person requirements within the EU supporting and advising teams involved in manufacture and supply of investigation medicinal products including supply management, QA, regulatory.
Manage quality and compliance risks by conducting risk assessments and ensuring risk mitigation actions are taken
Identify and recommend product and process quality improvements
Support the Celgene global contractor audit program
Support in establishing of technical/quality agreements
For non-product related duties:
Maintain quality management system of Celgene Distribution BV
Author and/or revise standard operating procedures and associated work instructions, as assigned
Review and provide recommendations on policies and standards, as required
Conduct internal and contractor audits, as required
Support external GMP/GDP site inspections, as required
Maintain compliance with personal training requirements
Assists in Quality Assurance Assessments of contractors and inputs into GMP/GDP audit program. This includes, as necessary:
Audit team member as required
Evaluating audit responses and reviewing corrective actions plans
Review and approve/reject batch records, both master production/packaging records and executed batch records of assigned contractors.
Disposition (release/withhold) drug product/substance batches of assigned products for distribution (or further processing) to each specific country/region of the world after confirming:
Conformance to specification
Compliance to regulatory/dossier requirements
Act as Member of Recall Committee as required
Generate, review and approve required controlled documents.
As per assignment, review, edit, negotiate improvements to, and approve contractor documentation, including:
OOSs / Excursions
Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
Ensure logs, databases and files related to the product quality activities are maintained
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE