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CMO Support Quality & Regulatory Specialist

Job Description

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 60,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Primary responsibility for this position is to work with CMO business partners to manage quality and regulatory topics by serving as the primary Q&R liaison between the drug sponsor and PETNET.  Responsibilities include but are not limited to the following:

  • support and facilitate site audits by drug sponsor including development of audit responses
  • conduct and/or support investigations in conjunction with the manufacturing site and/or drug sponsor
  • facilitate communication of and gain approval for exceptions, planned variances, change control, etc.
  • Process product complaints including conducting the investigation and writing the final report.
  • manage quality system metric reporting for drug sponsor product
  • facilitate meetings with drug sponsor (i.e., quality reviews, etc.)
  • support sponsor drug application supplements including addition of new manufacturing site
  • review and approve drug product and manufacturing site qualification data

Specific Requirements:

  • Responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents
  • Proactively identifies potential regulatory issues and recommends solutions to Q&R management.
  • Participate in or assist in development of regulatory submissions within assigned products.
  • Interacts with other project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
  • Interacts with internal and external partners as necessary to support product development and implementation
  • Product Complaint Management
  • Assist with internal and external audits
  • Assist with Exception/Investigation Closure
  • Liaison with CMO partner regarding daily Q&R related topics
  • Drives priorities and key issues as defined by Q&R management
  • Supports the preparation of responses to complex questions and comments from regulatory agencies.

Position Requirements:
3-4 years of experience in Regulatory Affairs and/or Quality Assurance in the pharmaceutical industry.  Prior experience with regulatory submission, complaint investigation and CMO Quality Relationship management desired.  Technical experience in PET Drug Manufacturing can substitute for specific Q&R experience.

Education:
BS/MS in a scientific discipline.  A degree in Chemistry or Microbiology is preferred.  

* High standard of professional ethics, integrity and trust.
* Excellent oral and written communication skills.
* Excellent planning, organizational and prioritizing skills.
* Consistently high professional image and demeanor.
* Strong interpersonal /group skills; capable of working collaboratively with colleagues in all functions.
* Attention to detail and accuracy.
* Able to effectively multi-task.
* Ability to interpret, understand and comply with domestic and international regulatory requirements.
* Ability to coordinate information from cross-functional disciplines.
* Flexible in responding to changing project priorities.
* Exercise good judgment in decision-making and sharing of sensitive information.
* Strong understanding of the drug development and regulatory process.
* Knowledgeable in the general principles of nonclinical development, CMC and clinical development.
* Flexibility to work on issues of diverse scope and apply knowledge gained to multiple tasks.
* Responds effectively to meet management objectives.

Required Travel:  10-20%

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.

(Note: Accommodations may be requested for certain medical or religious reasons)

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.

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Organization: Siemens Healthineers

Company: PETNET Solutions, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



Equal Employment Opportunity Statement
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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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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