Global Quality Assurance Manager (all genders) - limited to 2 years - part-time possible

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

As the Global Quality Assurance Manager, you will have multi-site responsibility for quality assurance aspects within IIB Program Framework. You will own the global processes by developing and deploying the global quality standard for OT qualification framework, ensuring alignment with IT QA and CSV Merck procedures and guidelines. The Global Quality Assurance Manager provides leadership and expertise on quality assurance processes and tools. In addition, you will have the responsibility to ensure that the sites are implementing the quality OT framework in a harmonized way.

Key responsibilities include:

• Develop the global standard OT qualification framework for equipment integration for new IT infrastructure platforms incl. R&R and clear line between equipment qualification and validation
• Define new equipment testing strategy to existing IT Qualification and CSV Validation frameworks
• Drive creation of templates for standard qualification, incl. standard URS for equipment integration to IT, Technical Specification, Technical Risk Assessment, Protocols and Reports
• Train the global and site teams on the new established Framework, Templates and testing strategies
• Ensure quality and regulatory compliance in accordance with documented procedures
• Be responsible for the development, implementation, and continuous improvement of OT qualification process
• Utilize risk management tools and aids for use by the organization in accordance with documented procedures
• Lead, acknowledge, develop, communicate & implement a quality strategy to ensure compliance for the sites and equipment in scope for the IIB Program

Who You Are:

• Bachelor's degree in a scientific discipline
• Minimum of 8+ years of successful experience in a quality leadership role with successful demonstration of the key quality assurance responsibilities.
• Very good understanding of industrial automation, IT infrastructure platforms, laboratory instruments and system integration for Data Integrity compliance
• Demonstrated experience in change and risk management, validation and qualification activities for GxP equipment in manufacturing and or QC laboratories
• Strong knowledge on cGxP, Data Integrity regulations, and quality best practices and guidelines (e.g. GAMP, PICS, CFR, ISO9001, ...)
• Basic cyber security knowledge for industrial environments (e.g. ISA-99, IEC-62443)
• Highly developed interpersonal, written, and verbal communication skills.
• Experience in working in international project management environment and to steer virtual teams
• Ability to establish collaborative relationships with various departments to deliver on quality commitments.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Strong problem-solving skills
• Strong computer skills, including CSV e-quality systems

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Job Requisition ID: 226341

Location: Darmstadt

Career Level: E - Professional (10+ years)

Working time model: full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone's health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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