Celgene Associate Director, QA - Qualified Person/Responsible Person (QP/RP) 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
The primary role will be to lead in the implementation, organising, managing, and execution of the quality assurance function and quality management system, to ensure product quality and compliance of relevant manufacturing and distribution activities with all regulatory and corporate requirements, for Celgene products within Europe and rest of world markets, as applicable.
In addition, this position is responsible for providing leadership and direction for contractors who provide manufacturing and / or logistics services for Celgene activities.
The Qualified Person/Responsible Person (QP/RP) is invested with the authority to make decisions with regards to product quality, safety, purity, and efficacy independent of other business interest. Products are for commercial and named patient supply use only.
Include, but are not limited to, the following:
For the assignedarea of Celgene International Quality Operations:
As required,act as Qualified Person / Responsible Person as per requirements of Celgenelicences, and execute functions in accordance with the professional code of conductof the joint professional bodies
Fulfil responsibleperson duties as defined in EU GDP Guidelines 2013/C 343/01 Section 2.2
Fulfil qualifiedperson duties as defined in article 51 of 2001/83/EC
Interpretinternational, regional, and local regulations and apply those regulationswithin the GMP/GDP environment
Establishand maintain appropriate operating licenses and/or registrations, such aswholesale dealers license, manufacturing/importation authorisation, etc. forCelgene
Participatein GMP or GDP related health authority inspections at Celgene Europe, respondto any noted observations, and ensure implementation of corrective actions
Managequality and compliance risks by conducting risk assessments and ensuring riskmitigation actions are taken
Conductfinal review and approval of non-routine quality investigations related tobatch deviations, batch disposition, validation activities, stability results,critical quality complaints, and other quality systems for assigned products asrequired
Identify andrecommend product and process quality improvements
Providemetrics and review monthly trending of deviations, CAPA, complaints, etc. forassigned products
For non-product related duties:
Establishand maintain the relevant quality management system
Authorand/or revise standard operating procedures and associated work instructions.
Review andprovide recommendations on policies and standards, as required
Conductinternal audits, as required
Support externalGMP/GDP site inspections, as required
Maintaincompliance with personal training requirements
Managecontractor quality assurance activities for assigned contractors to ensureproduct is manufactured, packaged, tested, released and distributed incompliance with all regulatory and corporate requirements.
Assists inquality assurance assessments of contractors and inputs into GMP/GDP auditprogram. Audit team member as required
Evaluatingaudit responses and reviewing corrective actions plans
Review andapprove/reject batch records, both master production/packaging records andexecuted batch records of assigned contractors.
Disposition (release/withhold)drug product/substance batches of assigned products for distribution (orfurther processing) to each specific country/region of the world.
Act asmember of recall committee as required
Generate,review and approve required controlled documents.
As perassignment, review, edit, negotiate improvements to, and approve contractordocumentation.
Draft orreview, negotiate with contractors, and recommend approval for quality agreements
Ensure logs,databases and files related to the product quality activities are maintained
BSc (orequivalent) in a technical or scientific discipline which meets educationalrequirements as described in Article 49 2001/83/EC
Eligible toact as Qualified Person (QP) and Responsible Person (RP) within EC/EEA
Extensivepharmaceutical quality assurance/control experience (equivalent to a minimum of8 years’ experience), including audit, batch record review, change control,complaint handling and investigations experience
Thoroughknowledge of pharmaceutical manufacturing, packaging, testing, and distributionprocesses and associated global regulatory GMP/GDP requirements (US and EU,particularly)
Demonstratedunderstanding of the processes and interactions essential for ensuring andmaintaining regulatory compliance
Excellentorganisational, project management and problem solving skills
Ideally,will have demonstrated team leadership and people management proficiencies
Excellentcommunication skills, including excellent written, interpersonal,collaboration, negotiation and dispute resolution skills, with a team orientedapproach
Leadership;ability to build trust and create collaborative environment and relationships; recognisesand effectively balances the interest and needs of QA with those of the organisation.
Strategicthinker who can balance near term objectives with long term goals and outcomes,evaluate risk and develop effective solutions through an integrated multi-disciplineddecision-making approach.
Associate Director, QA - Qualified Person/Responsible Person (QP/RP)
Location: Utrecht, 9, NL
Job ID: 17001784