Manager, Global Quality Investigations
1000 Mylan Inc.
At VIATRIS, we see healthcare not as it is but as it should be.
We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the Senior Manager, Regional Professional Services Strategic Sourcing role will make an impact:
Key responsibilities for this role include:
- Perform retrospective review of closed Investigations pertinent to complex products vertical comprising Biologicals/ Respiratory and Dermatology to determine investigations robustness and to ensure the implementation of appropriate corrective actions. - Review and participate in the investigations associated with the critical quality events/escalations and provide guidance for continuous compliance and quality improvement. - Review and participate in the investigations associated with the notification/escalation and provide guidance for continuous compliance and quality improvement. - Timely reporting of analyzed data through governance and appropriate escalation of critical findings to global and vertical quality management. - Perform the Gap Assessment of Global SOPs/ Policies with site SOPs and communicate to sites with opportunities for enhancements. - Prepare executive summaries and reports based on evaluations conducted. - Prepare and present monthly metrics summary for all key attributes associated with investigations review. - Routinely interact with all stakeholders at site, regional and global levels-
- Monitor and respond to key performance indicators from the investigational metrics across the assigned verticals/sites in order to mitigate business risk. - Up to 30% domestic and international travel is required. - Perform other duties as assigned by reporting manager and/or reporting manager's hierarchy.
The minimum qualifications for this role are:
- Minimum of a Master's degree (or equivalent) and minimum of 10 years of experience, higher education and qualifications are always advantage.
However, a combination of experience and/or education will be taken into consideration. - Must possess knowledge of all applicable regulatory agencies that govern the industry. - Must possess expert-level knowledge of Quality investigations, practices, processes, policies and procedures. - Must possess excellent leadership skills that encompass visionary, analytical, strategic, critical and systems thinking skills. - Strong communicator with the ability to influence others and solve problems through independent judgment and analysis.
Must demonstrate an exceptional degree of innovation, creativity, and resourcefulness. - Must demonstrate ability to make key decisions that affect the success of the Quality group and Viatris. - Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems. - Must possess computer skills and a working knowledge of Microsoft Office suite. - Proficiency in speaking, comprehending, reading and writing English is required.
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.
Viatris is an Equal Opportunity Employer.
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