1+ months

Department Lead Quality Assurance and Regulatory Compliance (m/f/d)

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. As we continue to develop healthcare products and expand our business globally, we are consistently looking for new talents.

Right now, we are seeking highly qualified candidates to fill the position:

**Department Lead Quality Assurance and Regulatory Compliance (m/f/d)**

at our PGS site Freiburg, Germany


+ Reporting to Director of Quality Operations

+ Direct Reports are the Senior Team Leads Quality Assurance Release, Quality Assurance Systems and Regulatory Site Compliance, the Quality Assurance Lean Deployment Lead and the Manager Customer Support Lead the different QA groups professionally, organizationally and in compliance with the respective guidelines and laws (AMG/AMWHV/GMP)

+ Budget preparation/-control in close cooperation with the QO Business Analyst

+ Support personnel planning and coordinate employee development/talent management

+ Ensure usage and improvement of "Lean Principles" throughout Quality Assurance

+ Customer liaison and support according to existing Quality Agreements Content check of NTMs (Notification to Management) and timely creation of US Field Alerts and further authorities communication

+ Manage and coordinate the Site Quality Review Team

+ As Qualified Person (QP) authorize process validation documents; team member of the Site Validation Committee


Education: university degree in natural science, PhD is a plus.

Experience: Minimum 10 years pharmaceutical experience in quality assurance and production, including leadership experience, including work in international companies. Extensive knowledge of current GMP and regulatory requirements

Qualification: Qualified Person (14 AMG)

Language: fluent German and fluent English is a must

Soft Skills: Strong Leader Behaviors - willing to lead by example and jump right in, Demonstrated desire to understand how things work and get to true root cause, Strong sense of ownership, Collaborative/Active Listener, Effectively manages stressful situations - able to focus on task at hand and focus others regardless of circumstances and stress induced pressure

Other Skills: Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.

**Equal Employment Opportunity**

Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding discrimination on the grounds of: age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage & civil partnership, pregnancy & maternity, political persuasion or trade union membership.

At Pfizer we are creating an organisation and promoting a culture that respects each individual's unique character and life experiences and reflects the diversity of our customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported, thus enabling superior business results.

To apply please visit www.pfizercareers.com .

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control


Posted: 2020-03-18 Expires: 2020-06-17

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