Head of Quality Assurance (m/f/d)

• Technical and disciplinary leadership of the QA team of approx. 6 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 marketing authorization documents (AmRadV, CTD dossiers)
• Ensuring the validation of computerized systems
• Preparation, accompaniment, and follow-up of authority inspections and customer audits
• Coordination of report preparation (Management Review, KPI Reports, PQRs, Stability Reports)
• Close cooperation 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 fluent English skills
• Structured, responsible way of working with a solution-oriented approach to challenges
• Strong communication skills with assertiveness and a confident demeanor
• Enthusiasm for a dynamic environment and continuous change

• Flex Office
  Want to change your workspace 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
  Want to work from home occasionally? With us, mobile working is possible up to 1x per week – in coordination with your team and suitable for 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 off 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.
• Effortless Lunch
  Don't feel like meal prepping? With Mealmates, your subsidized lunch comes to you conveniently.
• Support for Families
  We subsidize childcare for non-school children with up to €250 per month – so you can concentrate on your job and family with peace of mind.
• Experience More Together
  Besides work, fun shouldn't be neglected: summer parties, Christmas parties, and regular team events are part of our culture.
• Looking Ahead with Security
  We support you in thinking about tomorrow today – with our company pension plan.
• Further Development
  Your development is important to us: we support you with further training and individual development opportunities.
• Modern Work Environment
  To ensure you can work effectively, we provide you with modern equipment such as a laptop and – depending on your role – an iPhone.
• Team Culture
  Look forward to respectful interaction, flat hierarchies, and an open "DU" (informal 'you') culture.

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