Senior Manager, Quality Standards and Compliance, Global Patient Safety & Risk
Tap Growth ai
Date: 9 hours ago
City: Cambridge, MA
Contract type: Full time
We're Hiring: Senior Manager, Quality Standards and Compliance!
We are seeking an experienced Senior Manager to lead quality standards and compliance initiatives within our Global Patient Safety & Risk division. The ideal candidate will drive regulatory compliance, establish quality frameworks, and ensure patient safety across all operations while collaborating with cross-functional teams.
Location: Cambridge, MA
Work Mode: Work From Office
Role: Senior Manager, Quality Standards and Compliance, Global Patient Safety & Risk
Pay Scale: $183, 040 – $228, 800(Dependent on Experience)
What You'll Do
What We're Looking For
Bachelor’s degree in life sciences or related field.
Minimum of 5 years in the pharmaceutical or life sciences industry with a focus on PV operations,
quality, and compliance in a global environment.
Knowledge of relevant global pharmacovigilance guidance and regulations (e.g. FDA, EMA, MHRA,
Health Canada and International Conference on Harmonisation (ICH) guidelines, including Good
Vigilance Practices (GVP) guidelines). Experience in rare diseases therapeutic area at a global level is
an advantage.
Demonstrates expertise related to understanding the principles and application of quality and
regulatory compliance
Demonstrates ability to effectively communicate and influence the outcomes of the decision-
making process
Ready to make an impact? Apply now and let's grow together!
We are seeking an experienced Senior Manager to lead quality standards and compliance initiatives within our Global Patient Safety & Risk division. The ideal candidate will drive regulatory compliance, establish quality frameworks, and ensure patient safety across all operations while collaborating with cross-functional teams.
Location: Cambridge, MA
Work Mode: Work From Office
Role: Senior Manager, Quality Standards and Compliance, Global Patient Safety & Risk
Pay Scale: $183, 040 – $228, 800(Dependent on Experience)
What You'll Do
- Oversight and maintenance of the PSMF including provision of content to support PSMF
- Act as a key point of contact between GVP Quality Assurance and GPSRM to ensure collaboration
- Collaborate with GVP Quality Assurance to ensure the completion of annual pharmacovigilance
- Support PV audit activities on behalf of GPSRM in collaboration with GVP Quality Assurance
- Support PV regulatory authority inspection activities on behalf of GPSRM in collaboration with GVP
What We're Looking For
Bachelor’s degree in life sciences or related field.
Minimum of 5 years in the pharmaceutical or life sciences industry with a focus on PV operations,
quality, and compliance in a global environment.
Knowledge of relevant global pharmacovigilance guidance and regulations (e.g. FDA, EMA, MHRA,
Health Canada and International Conference on Harmonisation (ICH) guidelines, including Good
Vigilance Practices (GVP) guidelines). Experience in rare diseases therapeutic area at a global level is
an advantage.
Demonstrates expertise related to understanding the principles and application of quality and
regulatory compliance
Demonstrates ability to effectively communicate and influence the outcomes of the decision-
making process
Ready to make an impact? Apply now and let's grow together!
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resume