Director Quality (m/f/d)

Our client is a global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.

 

The Director of Quality is responsible for setting the strategic direction, properly staffing and maintaining the Quality Management Systems (QMS) to assure the site is complaint at all times. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality at the site is the most responsible person for batch disposition. The Director of Quality is responsible to provide project guidance and support and work with customers to resolve quality concerns as appropriate.

 

We are searching for a dedicated and highly motivated

Director Quality (m/f/d)

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    Baden-Württemberg

  • Art der Anstellung:

    permanent

  • Kennziffer:

    25967

  • Aktualisierung:

    2020-06-18

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Your tasks

  • Develop and implement Site Quality Plan, Quality Unit objectives and related procedures
  • Maintain and enhance an effective Quality Management System (QMS)
  • Interface with all other departments to ensure compliance with cGLP/cGMP
  • Monitor site compliance to FDA, EU and all other applicable requirements
  • Establish a process to review and Implements site procedures in alignment with the Corporate policies
  • Direct a team of Quality professionals. Provide development and disciplinary actions as needed to assure the department remains engaged and motivated
  • Training and supervision of pharmacists during the practical year
  • Supervision of pharmaceutical internships
  • GMP training for employees, trainees, pharmaceutical technicians and pharmaceutical workers
  • Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records
  • Ensure that batches are manufactured in accordance with customer requirements and approved specifications, if our client is responsible for market release
  • Evaluation of batch protocols
  • Release of finished goods according to §19 AMG.
  • Ensure that all necessary QC testing is performed on manufactured products.
  • Approve specifications, sampling instructions, test methods and other Quality Control procedures; to approve and monitor any contract analysts
  • Review and Approve site Annual Product Reviews
  • Ensure that all required validation activities are completed
  • Ensure the required initial and continuing training is carried out and adapted according to need
  • Responsible for ensuring the environmental monitoring and control of the manufacturing environment and plant hygiene
  • Require approval and monitoring of suppliers of materials
  • Ensure the proper designation and monitoring of storage conditions for materials and products
  • Serve as site's primary contact with both customers and regulatory agencies regarding quality/compliance issues
  • Analyze, resolve, or assist in solving compliance and customer issues
  • Ensure customer audits are managed for success and timely audit response letters
  • Prepare approve and manage QA departmental budget
  • Recruit/hire QA management and staff
  • Manage staff who each supervise diverse groups of audit/document control staff
  • Ensure that GLP/GMP documentation is backed up by secondary media and archived appropriately
  • Ensure that Document Control activities are compliant with EU, FDA and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required
  • Stay informed regarding industry trends, interpretation of regulations and application to the RTP site
  • All other duties as assigned

Your qualification

Education and Experience

  • Licence to practise as a pharmacist (Approbation als Apotheker) At least 10 years in a similar position in a pharmaceutical company quality organisation

 

Languages

  • German, main preference Native Speaker
  • English, Business fluent

 

Knowledge, Skills and Abilities

  • Ability to organize time for multiple tasks (major projects and daily functions)
  • Delivers assigned tasks on time
  • Schedules and executes work
  • Function and problem solve independently without supervision
  • Good communication and organizational skills
  • Formal presentation skills to co-workers or customers
  • Usually supplies and seeks information where exceptional tact and courtesy is needed
  • Ability to bring projects to a timely completion using applied systems
  • Good working knowledge of the subject area
  • Knowledge of cGMP, GLP, ICH, and EP,USP, BP regulations or guidelines
  • Expert knowledge as a qualified person according to § 14 AMG
  • Supply and seek information where exceptional tact and courtesy is needed
  • Has extensive knowledge of area of responsibility and considered an expert
  • Good understanding of the pharmaceutical industry and regulations applicable for a contract testing laboratory
  • Knowledge of a production/technical field such as pharmaceutical analysis at various stages of product development
  • Lead a group of 90-130 employees effectively

Your contact person

Bettina Cöppicus
Senior Personalberaterin

Address

Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg