Head of Quality Assurance (m/f/d)

• Technical and disciplinary leadership of the QA team of approx. 10 employees
• Further development of the Quality Management System (QMS) with regard to regulatory compliance and efficiency
• Ensuring compliance with GMP-/GDP- and MedCanG requirements
• Management of the core processes of the QMS: Document, Deviation, CAPA, Risk and Change Control Management, Complaints, Recalls and Self-Inspections
• Responsibility for the supplier and service provider qualification system as well as contract/quality agreement management
• Management of registration documents (AmRadV, CTD dossiers)
• Ensuring the validation of computerized systems
• Preparation, accompaniment, and follow-up of authority inspections and customer audits
• Coordination of report creation (Management Review, KPI Reports, PQRs, Stability Reports)
• Close collaboration with the Qualified Person (QP) and other departments, e.g., Supply Chain, Regulatory Affairs, as well as sister companies
• Reporting to management

• Completed degree in natural sciences or engineering (e.g., Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Process Engineering) or many years of professional experience in relevant fields
• Several years of professional experience in quality assurance in a regulated environment, preferably in the pharmaceutical or medical device industry
• At least three years of leadership experience
• In-depth knowledge of relevant regulations (e.g., AMG, AMWHV, GMP-/GDP guidelines as well as MedCanG and/or BtMG, AmRadV)
• Very good German language skills, both written and spoken, as well as business fluent English skills
• Structured, responsible way of working with a solution-oriented approach to challenges
• Strong communication personality with assertiveness and confident demeanor
• Enthusiasm for a dynamic environment and continuous change

• Flex Office
  Would you like to change your workplace from time to time? With our „Flex Office“ model, you can also work flexibly from our offices in Munich, Hamburg, Leipzig, or London – for more variety, new perspectives, and maximum flexibility in your daily work.
• Mobile Working
  Would you like to work from home occasionally? With us, mobile working is possible up to 1x per week – in coordination with your team and in line with your tasks.
• Time for You
  Look forward to 30 days of vacation per year with a 5-day, 40-hour week – you also get half days on Christmas Eve and New Year's Eve as a gift.
• Urban Sports Club
  Stay active, when and how it suits you: With the Urban Sports Club („Classic“ tariff) – with only a small co-payment.
• Lunch Without Hassle
  Don't feel like cooking in advance? With Mealmates, your subsidized lunch comes to you uncomplicatedly.
• Support for Families
  We subsidize childcare for non-school-aged children with up to €250 per month – so you can concentrate on your job and family in a relaxed way.
• Experiencing More Together
  Besides work, fun should not be neglected: Summer parties, Christmas parties, and regular team events are part of our culture.
• Focus on Benefits
  We support you in thinking about tomorrow today – with our company pension scheme.
• Further Development
  Your development is important to us: We support you with further training and individual development opportunities.
• Modern Working
  To ensure you can work well, we provide you with modern equipment such as a laptop and – depending on the role – an iPhone.
• Team Culture
  Look forward to a respectful collaboration, flat hierarchies, and an open „DU“-culture.

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