Analytik NEWS
Online Laboratory Magazine
12/01/2022

Director Quality Control (m/f/d)

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What you have to offer:

Education:
  • Bachelor's degree in relevant scientific discipline (e.g., Biology, Chemistry, Pharmacy) additional qualifications (MSc, PhD, MBA)
Professional experience:
  • At least 6-8 years of industry experience in pharmaceutical industry
  • Experience supervising direct reports and organizing teams
  • Regulatory and legal requirements experience
  • Working knowledge of relevant local and international regulations
  • Strong understanding of pharmaceutical business and quality governance
  • Broad knowledge and practical experience of analytical sciences and technologies
  • Strong quality and analytical mindset
  • Experience in hosting and collaborating with national or international regulatory agencies
Languages:
  • Fluent written and verbal English
Competencies:
  • Strong leadership and excellent internal personal skill
  • Sense of ownership and honesty (proactive handling of errors)
  • Pronounced team & communication skills, self-driven and learning capacity
  • Constructive work habits, flexibility, solution orientation, job ownership, quality appreciation
  • Conceptual, analytical skills and ability to identify complex problem solutions
  • Ability to plan and manage in a fast-paced environment
  • Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
  • Ability to navigate through ambiguity and rapid growth and adapt to change
  • Honest, open minded, transparent, solution driven, continuous improvement focus

Your main responsibilities are:

  • Close collaboration with global Head of QC to implement all QC-related processes according to defined global standards
  • Guide and oversee set-up and commissioning of analytical and microbiological QC labs including equipment qualification
  • Support hiring for locally required QC employees and ensure proper training and qualification
  • Ensure successful transfer/validation of time-critical compendial test methods
  • Implement effective and reliable sample management and raw material testing and release processes
  • Interface to global quality control organization to ensure state-of-art testing strategy and ensure continuous improvement
  • Recruits, leads, motivates, and develops assigned direct reports in accordance with company leadership principles
  • Ensure the implementation of testing processes with regard to cost efficiencies, ecology, quality, and safety to maintain the GMP status
  • Approve starting materials, packaging materials, bulk and finished products (Drug Substance and Drug Product)
  • Ensure that all necessary testing is carried out and the associated records evaluated
  • Approve specifications, sampling instructions, test methods and other Quality Control procedures
  • Approve and monitor any contract laboratories
  • Ensure the qualification and maintenance of his/her department, premises and equipment
  • Ensure that the appropriate validations are done
  • Ensure that the required initial and continuing training of his/her department personnel is carried out and adapted according to need
  • Measuring KPIs and supporting quality reviews
  • Ensure that globally assigned activities (full cycle of drug substance and drug product testing) are performed in a timely manner while observing all internal and regulatory requirements
  • Lead investigations for OOSs in collaboration with subject matter experts
  • Ensure that change control procedures are initiated and executed appropriately


» Job description


Employer:
BioNTech
Location:
Singapur
Temporary:
No
Part-time:
No