Senior Manager QA (QA Compliance)

The role is responsible for internal audits, external audits and regulatory inspection management and supporting Quality processes. Acts as a check and balance for internal operations, ensures alignment to global quality, internal and general GxP requirements for vendor and material management. Your main responsibilities are: Responsible to lead and direct the assigned Quality Process Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations Owns policies and procedures of the assigned Quality Process where applicable Partners with global and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process Ensures deviations from assigned Quality Process are documented and investigated Ensures QA personnel are qualified and trained to perform assigned tasks Support technology transfer activities Develops strategies for assigned Quality Process to be fit for purpose, site operation readiness, including continuous improvements and ensure a state of inspection readiness Leads inspection and audit preparations Lead/coordinates the relevant forums/activities of the assigned Quality process (e.g. Quality Management Review, Quality Risk Review, APQR) Escalates quality and compliance risks to Head of Department, QA Supports improvement initiatives, programs and projects of the assigned Quality Process Build, maintain and develop a team to support the deliverables of this assigned Quality Process What you have to offer: University degree/Advanced Degree in Science (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) At least 12 years’ professional working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry with > 3 years people management experience Extensive knowledge in Quality Management System concepts and strong understanding of pharmaceutical business and regulatory governance/framework Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing Ability to be agile and effectively collaborate in a dynamic, cross-functional environment High degree of conscientiousness and diligence Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment Self-starter and learning capacity Sense of ownership and honesty (proactive handling of errors) Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment Expectation to be hands on, interactive and display practical leadership Fluent in written and verbal English BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience. How to apply: Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form. Please note: Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your Recruiter. We are looking forward receiving your application. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!#J-18808-Ljbffr