Associate Director, QA - Qualified Person/Responsible Person (QP/RP) Krimpen aan den IJssel 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 assigned area of Celgene International Quality Operations:
- As required, act as Qualified Person / Responsible Person as per requirements of Celgene licences, and execute functions in accordance with the professional code of conduct of the joint professional bodies
- Fulfil responsible person duties as defined in EU GDP Guidelines 2013/C 343/01 Section 2.2
- Fulfil qualified person duties as defined in article 51 of 2001/83/EC
- Interpret international, regional, and local regulations and apply those regulations within the GMP/GDP environment
- Establish and maintain appropriate operating licenses and/or registrations, such as wholesale dealers license, manufacturing/importation authorisation, etc. for Celgene
- Participate in GMP or GDP related health authority inspections at Celgene Europe, respond to any noted observations, and ensure implementation of corrective actions
- Manage quality and compliance risks by conducting risk assessments and ensuring risk mitigation actions are taken
- Conduct final review and approval of non-routine quality investigations related to batch deviations, batch disposition, validation activities, stability results, critical quality complaints, and other quality systems for assigned products as required
- Identify and recommend product and process quality improvements
- Provide metrics and review monthly trending of deviations, CAPA, complaints, etc. for assigned products
- Establish and maintain the relevant quality management system
- Author and/or revise standard operating procedures and associated work instructions.
- Review and provide recommendations on policies and standards, as required
- Conduct internal audits, as required
- Support external GMP/GDP site inspections, as required
- Maintain compliance with personal training requirements
- Manage contractor quality assurance activities for assigned contractors to ensure product is manufactured, packaged, tested, released and distributed in compliance with all regulatory and corporate requirements.
- Assists in quality assurance assessments of contractors and inputs into GMP/GDP audit program. 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.
- 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.
- 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
- 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 (QP) and Responsible Person (RP) within EC/EEA
- Extensive pharmaceutical quality assurance/control experience (equivalent to a minimum of 8 years experience), including audit, batch record review, change control, complaint handling and investigations experience
- Thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly)
- Demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance
- Excellent organisational, project management and problem solving skills
- Ideally, will have demonstrated team leadership and people management proficiencies
- Excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team oriented approach
- Leadership; ability to build trust and create collaborative environment and relationships; recognises and effectively balances the interest and needs of QA with those of the organisation.
- Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate risk and develop effective solutions through an integrated multi-disciplined decision-making approach.
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