Senior Manager, Global Quality Digital Systems
Viatris
June 27, 2026
Remote friendly (United States)
United States
IT
Senior Manager, Global Quality Digital Systems
Key Responsibilities:
- Provide support for standardized digital quality systems programs.
- Evaluate existing digital quality systems worldwide and train key personnel to global policies.
- Support global inspection preparedness, audit response, and CAPA related to digital quality systems.
- Perform independent research of regulations (e.g., FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW; ICH, GxP).
- Independently review departmental and corporate policies/procedures and interpret complex regulations.
- Facilitate meetings with all levels of Management.
- Provide guidance to manage digital quality systems to meet industry, regulatory, and corporate expectations.
- Review/approve system validation documentation (assessment reports, project plans, validation strategy, global quality directives, user requirements, IQ/OQ/PQ, validation summary reports, and change requests) within set timelines.
Minimum Qualifications:
- Bachelor’s degree in a science-related discipline and 6+ years directly relevant experience; Master’s preferred (10+ years Quality/Regulatory Affairs, or 8+ years with a Master’s; combination considered).
- Sound knowledge of cGMP regulations; familiarity with Global Systems concepts.
- Strong written/oral communication; independent decision-making; ability to lead discussions; Microsoft Office proficiency.
- Supervisory responsibilities per organizational policies/laws.
- Quality certifications preferred.
- Ability to read/interpret complex documents; write comprehensive reports; present to organizational groups.
- Ability to perform computations/statistical and graphical data analysis; pharmaceutical calculations preferred.
- Ability to solve moderately complex problems using procedures and analysis.
- English proficiency required.
Work/Travel:
- Office setting; up to ~30% travel.
Compensation:
- Salary range: $95,000–$193,000 (varies by skills, experience, location).
Key Responsibilities:
- Provide support for standardized digital quality systems programs.
- Evaluate existing digital quality systems worldwide and train key personnel to global policies.
- Support global inspection preparedness, audit response, and CAPA related to digital quality systems.
- Perform independent research of regulations (e.g., FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW; ICH, GxP).
- Independently review departmental and corporate policies/procedures and interpret complex regulations.
- Facilitate meetings with all levels of Management.
- Provide guidance to manage digital quality systems to meet industry, regulatory, and corporate expectations.
- Review/approve system validation documentation (assessment reports, project plans, validation strategy, global quality directives, user requirements, IQ/OQ/PQ, validation summary reports, and change requests) within set timelines.
Minimum Qualifications:
- Bachelor’s degree in a science-related discipline and 6+ years directly relevant experience; Master’s preferred (10+ years Quality/Regulatory Affairs, or 8+ years with a Master’s; combination considered).
- Sound knowledge of cGMP regulations; familiarity with Global Systems concepts.
- Strong written/oral communication; independent decision-making; ability to lead discussions; Microsoft Office proficiency.
- Supervisory responsibilities per organizational policies/laws.
- Quality certifications preferred.
- Ability to read/interpret complex documents; write comprehensive reports; present to organizational groups.
- Ability to perform computations/statistical and graphical data analysis; pharmaceutical calculations preferred.
- Ability to solve moderately complex problems using procedures and analysis.
- English proficiency required.
Work/Travel:
- Office setting; up to ~30% travel.
Compensation:
- Salary range: $95,000–$193,000 (varies by skills, experience, location).