site found HR One - Executive search and project staffing

Job opportunities All vacancies

Manager QA/QP

Job description



  • Responsible for leading and directing Quality staff including managing their performance and supporting their development.
  • Manage resource planning (e.g. shift roster, holidays) per business need
  • Responsible for achieving Plant QA Key Performance Indicators
  • Provide real-time QA oversight and support for production operations.
  • Collaborate with operations to resolve quality and compliance issues, including but not limited to Change Controls, NCs and CAPAs.
  • Ensures that changes that could potentially impact product quality are assessed according to procedures (ex: site change control, Maximo)
  • Review and approve cGMP records (e.g., Non Conformances, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
  • Alerts senior management of quality, compliance, supply and safety risks
  • Support and represent Quality during audits and inspections
  • Support Lean Transformation and Operational Excellence initiatives, drives continuous improvement initiatives within plant QA, and drive together with production management reduction of repeating events within plant QA and production.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Execute batch disposition


  • Decision in approval worked hours for contingent workers, holidays
  • Decision related to MAP process
  • Decision as Qualified Person as laid out in EU Directive 2001/83/EC


  • QA batch review and issue resolution (e.g. exceptions, NCs) to enable batch release within agreed timelines.
  • Batch Disposition within agreed timelines
  • Documentation, NC, CAPA, review and approval within agreed timelines

: The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

Minimum Requirements

  • Thorough knowledge of the processes involved in clinical and commercial manufacturing.
  • Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and GDP guidelines 2013/C 68/01 chapter 2.2 (Responsible Person).
  • Master’s degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology or equivalent
  • Typically 2+ years of related professional experience
  • Sound knowledge of Good Manufacturing Practice and Good Distribution Practice
  • Relevant experience in dealing with Non Conformances and Change Control records
Skills and personality

Preferred Requirements

  • 3 years of professional experience in pharmaceutical environment (GMP)
  • 1 year managerial experience
  • Customer oriented and service minded
  • Experience in (bio)pharmaceutical production environment, in particular packaging and labeling
  • Good problem solving skills
  • Effective communication skills at multiple levels and areas (inside and outside of Quality)
  • Thorough decision making skills and  ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc.


  • Coaching
  • Communication
  • Decision quality
  • Problem solving – making complex decisions
  • Compliance rule-following attitude with high degree of attention to detail.

Executive search


minimum 3 years


Master's Degree


Dutch, English


Pharmaceutical Packaging Industry



Job type



Submit your CV

Please submit your CV through the form below and we will contact you shortly.



Feel free to
drop in for a coffee.