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CMO Support Quality & Regulatory Specialist

Job Description

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare.  For everyone. Everywhere.

 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as CMO Support Quality & Regulatory Specialist to ensure compliance with quality requirements and applicable regulations as well serving as the primary Q&R liaison between the drug sponsor and PETNET.

 

Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

 

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world.  We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers

This is a role well suited to an ambitious professional, looking for the next step in their career. As a CMO Support Quality & Regulatory Specialist, you will be responsible for:

  • The interactions with drug sponsor regarding daily Q&R related topics
  • The review and approval of drug product and manufacturing site qualification data
  • The support and facilitation of site audits by drug sponsor including gathering/organizing requested information and any development of audit responses
  • The support of sponsor drug application supplements including addition of new manufacturing sites
  • The support of investigations in conjunction with the manufacturing site and/or drug sponsor
  • Facilitating communication and approval for exceptions, planned variances, change controls, etc.
  • Supporting or facilitating the investigation of product complaints and reviewing or writing the final report
  • Managing quality system metric reporting for drug sponsor products
  • Facilitating and leading meetings with drug sponsors (i.e., routine meetings, quality reviews, etc.)
  • Ensure compliance with regulatory changes, drug sponsor expectations, and patient/product safety

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

  • You have experience interacting with internal and external partners to support product development and implementation
  • You have deep knowledge of PET GMP regulations and associated guidance documents
  • You have a strong understanding of the drug development and regulatory process
  • You have technical experience with PET Drug Manufacturing in a GMP regulated environment
  • You have CMO Quality and/or Regulatory relationship management
  • You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
  • You are willing to travel and are flexible in responding to changing project priorities

Required skills to have for the success of this role

  • BS/MS in a scientific discipline.  A degree in Chemistry is preferred.
  • Minimum of 15 years experience in Quality Assurance and Regulatory Affairs in the pharmaceutical industry. 
  • Direct experience with FDA audits and audit responses
  • Prior experience with FDA drug product regulatory submissions, including investigational and new drug submissions.
  • Attention to detail and accuracy.
  • Flexible in responding to changing project priorities.
  • Flexibility to work on issues of diverse scope and apply knowledge gained to multiple tasks.
  • Exercise good judgment in decision-making and sharing of sensitive information.
  • Technical experience in PET Drug Manufacturing
  • Willing to travel up to 20%

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date, except where prohibited by state law.  Accommodations may be requested for certain medical or religious reasons.  If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer.  Details on how to submit approval will be provided by your recruiter.  An accommodation approval must be confirmed prior to your start date.  A start date cannot be confirmed until the accommodation has been reviewed.  An accommodation is based on your role.  If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new role.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.


PETNET

#LI-AW1

Organization: Siemens Healthineers

Company: PETNET Solutions, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



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Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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