Quality Management Specialist II
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Quality Management Specialist II β Make an Impact at the Forefront of Innovation
The Quality Management Specialist II provides Quality Management support for operational teams within an assigned country. The role supports quality investigations, performs compliance checks, contributes to the development of corrective and preventative actions and supports audit and inspection readiness. The Specialist provides guidance on SOP and QMS requirements, supports the review and accuracy of quality documentation, and contributes to maintaining operational compliance, data integrity and inspection readiness. The role may provide informal coaching to junior team members but does not hold people management responsibilities.
Day to day responsibilities
Performs quality investigations of moderate complexity under oversight.
Supports elements of investigations through documentation checks, data verification, factual summaries.
Provides quality consultation on SOP/QMS questions.
Performs compliance checks and quality monitoring tasks.
Contributes to CAPA activities within defined processes.
Supports audit/inspection readiness tasks.
Assists in delivering or reinforcing SOP/QMS/system training.
Collaborates with site teams and QAC as needed.
May provide informal coaching to junior staff.
Ensures country-level compliance and inspection readiness.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job including a minimum of 2 years of related experience; or an advanced degree with limited experience; or equivalent work experience.
Knowledge, Skills, and Abilities:
Solid understanding of GCP/SOP/QMS.
Strong attention to detail.
Basic investigation / RCA contribution skills.
Good organisational & time-management skills.
Good interpersonal/consultation skills.
Ability to communicate quality expectations clearly.
Proficiency with documentation systems & MS Office.
Working Conditions and Environment:
Indoor environment
Extended periods of computer work
High-paced or high-pressure environment
Physical Requirements:
Standing: Remaining on oneβs feet in an upright position β Occasionally / Frequently / Constantly
Sitting: Remaining seated to perform tasks β Occasionally / Frequently / Constantly
Repetitive Motions: Performing the same hand, arm, or body movement repeatedly β Occasionally / Frequently / Constantly
Talking: Expressing or exchanging information orally β Occasionally / Frequently / Constantly
Hearing: Perceiving the nature of sounds β Occasionally / Frequently / Constantly
Vision: Clarity of vision at various distances β Occasionally / Frequently / Constantly
Fine Motor Skills: Handling small objects with fingers β Occasionally / Frequently / Constantly
Travel: Required to travel for work-related tasks β (5% Travel Expectation) β Occasionally
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Quality Management Specialist II β Make an Impact at the Forefront of Innovation
The Quality Management Specialist II provides Quality Management support for operational teams within an assigned country. The role supports quality investigations, performs compliance checks, contributes to the development of corrective and preventative actions and supports audit and inspection readiness. The Specialist provides guidance on SOP and QMS requirements, supports the review and accuracy of quality documentation, and contributes to maintaining operational compliance, data integrity and inspection readiness. The role may provide informal coaching to junior team members but does not hold people management responsibilities.
Day to day responsibilities
Performs quality investigations of moderate complexity under oversight.
Supports elements of investigations through documentation checks, data verification, factual summaries.
Provides quality consultation on SOP/QMS questions.
Performs compliance checks and quality monitoring tasks.
Contributes to CAPA activities within defined processes.
Supports audit/inspection readiness tasks.
Assists in delivering or reinforcing SOP/QMS/system training.
Collaborates with site teams and QAC as needed.
May provide informal coaching to junior staff.
Ensures country-level compliance and inspection readiness.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job including a minimum of 2 years of related experience; or an advanced degree with limited experience; or equivalent work experience.
Knowledge, Skills, and Abilities:
Solid understanding of GCP/SOP/QMS.
Strong attention to detail.
Basic investigation / RCA contribution skills.
Good organisational & time-management skills.
Good interpersonal/consultation skills.
Ability to communicate quality expectations clearly.
Proficiency with documentation systems & MS Office.
Working Conditions and Environment:
Indoor environment
Extended periods of computer work
High-paced or high-pressure environment
Physical Requirements:
Standing: Remaining on oneβs feet in an upright position β Occasionally / Frequently / Constantly
Sitting: Remaining seated to perform tasks β Occasionally / Frequently / Constantly
Repetitive Motions: Performing the same hand, arm, or body movement repeatedly β Occasionally / Frequently / Constantly
Talking: Expressing or exchanging information orally β Occasionally / Frequently / Constantly
Hearing: Perceiving the nature of sounds β Occasionally / Frequently / Constantly
Vision: Clarity of vision at various distances β Occasionally / Frequently / Constantly
Fine Motor Skills: Handling small objects with fingers β Occasionally / Frequently / Constantly
Travel: Required to travel for work-related tasks β (5% Travel Expectation) β Occasionally