Viatris Inc.

Site Self Inspection Lead, Quality Assurance - 1st Shift

Viatris Inc. • $95K — $193K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Extensive knowledge of pharmaceutical cGMP and global regulations (FDA, EMA, ICH, ISO 9001).
  • Strong understanding of quality system requirements and application of global GMPs.
  • Bachelor's degree in Science, Engineering, or related field with 10+ years of experience in a GXP setting.
  • Experience in Quality Assurance across multiple functions is preferred.
  • Combination of experience and education may be considered.

Responsibilities

  • Create and track the site self-inspection plan and schedule.
  • Liaise with Site Leadership and Global Operations Auditing for alignment on inspection plans.
  • Lead and participate in self-inspections, ensuring accurate documentation and communication.
  • Evaluate and track CAPA items from inspections, guiding site functions for effectiveness.
  • Prepare annual trend reports and facilitate bi-monthly reviews on site learnings with global personnel.
  • Manage the Site Audit Module and related procedures.
  • Support the overall Inspection Readiness Plan and assist in Board of Health inspections.
  • Contribute to global operations audits and perform third-party supplier audits as necessary.
  • Participate in global audit training and coach site teams as required.
  • Support site quality culture initiatives.

Benefits

  • Competitive salaries and benefits.
  • Inclusive work environment.
  • Opportunities to make a real impact on people's lives.
Full Job Description
Every day, we rise to the challenge to make a difference and here’s how the Site Self Inspection Lead will make an impact:

Key responsibilities for this role include:


  • Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda.
  • Liaising with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedule and scope.
  • Leading and participating in site self-inspections. Ensuring each self-inspection is appropriately recorded and communicated. Performing frequent unplanned and planned walk through inspections of the facility.
  • Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed.  Ensuring that CAPAs are verified for effectiveness.
  • Prepare annual trend reports for site self-inspection data and collaborate across Viatris to identify Global and/or regional opportunities. Facilitate bi-monthly reviews with site and global personnel to discuss site learnings and opportunities.
  • Responsible for Site Audit Module and associated processes and procedures.
  • Support overall site Inspection Readiness Plan, participating as required in site Board of Health inspections.
  • Participate in Global Operations Audits of Viatris facilities.
  • Perform external audits of third party suppliers as aligned with site and GOA requirements.
  • Participate in global audit training and disseminate relevant detail to site teams. Provide training and coaching as required to broader site self-inspection team.
  • Support any of the site quality culture initiatives.

 

The minimum qualifications for this role are:


  • Must possess extensive knowledge and understanding of pharmaceutical cGMP and global government regulations, including Viatris policies, procedures and associated documents (corporate, regional, site), local regulations, US FDA, WHO  EMA, ICH and ISO 9001 (as applicable to the site).
  • Possess an in-depth knowledge of quality system requirements; including a demonstrated ability to evaluate and apply global GMP’s to support evaluation and enhancement to site systems and processes.
  • Minimum of a Bachelor's degree in Science, Engineering, or related technical discipline with at least 10 years’ experience in a GXP setting, extending across a range of functions inclusive of Quality Assurance. However, a combination of experience and/or education will be taken into consideration. 

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

About Viatris Inc.

They believe in healthcare as it should be empowering people worldwide to live healthier at every stage of life. Because of their unwavering belief that better access leads to better health, they leverage their best in class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

Viatris Inc. Careers

Join Viatris Inc., a global healthcare leader dedicated to empowering people to live healthier at every stage of life. We are currently expanding our team and offer a variety of job opportunities that promise not only professional growth but also a chance to make a meaningful impact. Work You’ll Do At Viatris Inc., you will collaborate with skilled professionals to drive innovation and deliver on our mission to provide access to high-quality medicine to the world's population. Our diverse team is our strength, and we thrive on creativity and the unique perspectives each member brings. Explore a range of positions—from research and development to marketing and sales—where you can leverage your skills to advance healthcare solutions. Our commitment to leadership in the industry is unwavering, and we equip our team with the tools they need to succeed. Viatris Inc. offers robust benefits designed to support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to retirement plans and wellness programs, we ensure our team is taken care of. Internship Programs Kickstart your career with Viatris Inc. through our internship programs. Gain invaluable industry experience, enhance your resume, and develop skills that will serve you throughout your career. Our internships provide a platform for learning and innovation, and a chance to work on real-world challenges in a supportive environment. Professional Growth and Development We believe in nurturing our employees' professional paths with extensive training and development programs that encourage continuous learning. Whether it’s leadership training, diversity initiatives, or career workshops, Viatris Inc. is committed to helping you grow at every level of your career. Join Our Team Are you ready to make a difference? Search for open positions that match your skills and interests. We are looking for passionate, curious, and solution-driven team players who are ready to take their career to the next level. Stay Connected Keep up to date with the latest at Viatris Inc. by joining our network. Follow us for career tips, company updates, and industry insights that can help you stay ahead in your professional journey. Connect with us to learn more about our culture and the exciting opportunities that await. Apply Now Discover the impact you could make with a career at Viatris Inc. Explore job opportunities, submit your resume, and prepare for an interview that could set you on a path to success. We are hiring now and looking forward to adding innovative and driven individuals to our team. Join Viatris Inc. today and be part of a global healthcare leader where your work matters and your career thrives.
Learn more about Viatris Inc.
Size
35,000 employees
Market Cap
$13 billion
Industry
Net Income
-$669.9 million
5 Year Trend
+10.1%
Revenue
$11.9 billion
NASDAQ

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