Vacancy Associate Director QP (qualified person) – Utrecht
For a global organisation in the pharmaceutical market that focuses on, among other things, cell therapy, we are looking for an EU Qualified Person / Manager QA.
In this position as Associate Director QP you are responsible for providing leadership and direction to the suppliers who provide the production and/or logistics services for the activities. You have full authority to make decisions regarding product quality, safety, purity, efficacy and independence from other business interests. You will also lead the implementation, organisation, management and execution of the quality assurance function and the quality management system.
- Acting as a QP according to the requirements of the licenses and in accordance with the code of professional conduct of the joint professional associations
- Interaction with executive level employees at external contractors
- Prepare and maintain appropriate operating licenses and/or registrations, such as wholesale dealer license, manufacturing/import authorization, etc.
- Participate in GMP or GDP-related health authority inspections as needed, respond to all noted observations and ensure implementation of corrective actions
- Manage quality and compliance risks by performing risk assessments and ensuring 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
- Keeping track of statistics, deviations, CAPAs, complaints, etc.
- Setting up and maintaining the quality management system
- Drafting and/or revising standard work procedures and associated work instructions
- Assess and if necessary make recommendations on policies and standards
- Conduct internal audits and support external GMP/GDP site inspections
- Managing quality assurance activities to ensure that the product is manufactured, packaged, tested, released and distributed in accordance with all legal and company requirements
- Leading discussions with the contractor on quality-related topics, such as complaints, change management, deviations, OOSs, processes, methods, procedures, documentation, etc.
- Resolving disputes with the supplier on quality related topics
- Recommend quality related improvements to the supplier
- Oversee the completion of supplier’s quality-related activities, such as process, method and procedure improvements, quality investigations, corrective and preventive actions, etc.
- Assist with quality assurance assessments of suppliers and input into the GMP / GDP audit program. This includes, as needed: Audit Team Member, Evaluating Audit Responses and Reviewing Corrective Action Plans
- Review and approve/reject batch records, both master production/packaging records and executed batch records
- Disposition (release/denial) batches of drugs/substances of assigned products for distribution (or further processing) to any specific country/region of the world upon confirmation of: Compliance with specification, Regulatory compliance/file requirements, Acceptable deviations
You are the ideal candidate if you meet the following requirements:
- You have at least 7+ demonstrable work experience in a QP position
- You have completed an MSc degree (or equivalent) in a technical or scientific direction
- You have in-depth knowledge of pharmaceutical production, packaging, testing and distribution processes and associated global regulatory GMP / GDP requirements (particularly the US and EU)
- You have demonstrable experience in strategic thinking and emergency planning
- You have excellent communication skills including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team-oriented approach
- Leadership; the ability to build trust and create a collaborative environment and relationships
- Effective planning and recruiting skills to identify strong achievers, hire suitable staff and build a high-performing organisation
- The ability to anticipate resource needs and help prioritise
- You are a strategic thinker who can balance short-term goals with long-term goals and results, evaluate risks and develop effective solutions through an integrated multidisciplinary decision-making approach
- You have excellent organisational, project management and problem-solving skills
This organisation can offer you the following:
- Salary between €90,000.- – €130,000.- based on knowledge and experience
- A bonus between 10 and 15%
- A car scheme
- Excellent pension
- Good secondary employment conditions
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Associate | Biotech/Pharma division
+31 6 58 81 46 32
+31 23 754 86 60