Manager Quality Assurance GxP - East Coast Candidates Only
Manager Quality Assurance GxP - East Coast Candidates Only
Posted on :
11-03-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-03-2025
Job Description
Job Title: Manager Quality Assurance GxP (GVP) East Coast Candidates Only
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Executive
Job Description Summary
The Manager Quality Assurance – GxP (GVP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Pharmacovigilance Practice (GVP) compliance for pre and postmarketed products.
The incumbent is responsible for QA oversight and support of pharmacovigilance function. This involves engaging and collaborating with crossfunctional internal and external teams to evaluate processes procedures and activities for adherence to relevant industry standards regulatory guidelines and company Standard Operating Procedures (SOPs) as appropriate.
They will assist in inspection readiness activities.
The incumbent will support and/or conduct internal and external/vendor GVP audits of pharmacovigilance processes safety vendors distributors market research vendors patient support programs etc.
The Manager Quality Assurance – GxP (GVP) supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Responsibilities
Job Description:
Expected Base Salary Range
$110400 – 139000. The base salary offered will be contingent on assessment of candidate education level background and experience relative to the requirements of the position they are being considered for as well as review of internal equity.
In addition to base salary PTC employees are also eligible for short and longterm incentives. All eligible employees may also enroll in PTC’s medical dental vision and retirement savings plans.
EEO Statement
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals regardless of race color national origin gender age physical characteristics social origin disability religion family status pregnancy sexual orientation gender identity gender expression disability veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
The Manager Quality Assurance – GxP (GVP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Pharmacovigilance Practice (GVP) compliance for pre and postmarketed products.
The incumbent is responsible for QA oversight and support of pharmacovigilance function. This involves engaging and collaborating with crossfunctional internal and external teams to evaluate processes procedures and activities for adherence to relevant industry standards regulatory guidelines and company Standard Operating Procedures (SOPs) as appropriate.
They will assist in inspection readiness activities.
The incumbent will support and/or conduct internal and external/vendor GVP audits of pharmacovigilance processes safety vendors distributors market research vendors patient support programs etc.
The Manager Quality Assurance – GxP (GVP) supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Responsibilities
Job Description:
- Partners with Pharmacovigilance function to ensure GVP compliance. Assists in identifying and communicating pharmacovigilancerelated risks and opportunities for process improvement.
- Performs internal and external audits as assigned to assure compliance with GVP regulations and guidelines.
- Communicates audit results to internal stakeholders and writes audit reports.
- Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs).
- Participates in regulatory authority inspections and assists with GxP inspection readiness activities.
- Maintains effective relationships with colleagues and other departments by working collaboratively to deliver high quality service to the organization.
- Ensures appropriate and timely escalation of quality issues including issues of significant deviations to QA Management and makes appropriate recommendations for correction and improvement as may be necessary.
- Engages in quality system continuous improvement initiatives to enforce the quality culture.
- Perform other tasks and assignments as needed and specified by management.
- Bachelor’s degree in scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance or related role in a pharmaceutical biotechnology or related environment.
- Knowledge and understanding of global GVP regulations predominantly EMA and FDA.
- Experience leading and/or conducting QA audits.
- Demonstrated ability to develop and foster positive collaborative relationships with internal staff as well as with external thirdparty vendors.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively as required in a fastpaced matrixed team environment consisting of internal and external team members.
- Analytical thinker with excellent problemsolving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning organization and time management skills including the ability to support and prioritize multiple projects.
- Pharmacovigilance (PV) Operations experience.
- Experience writing and reviewing SOPs.
- Quality management System (QMS) management experience.
- Registered GxP Quality Assurance Certifications.
- Experience supporting regulatory agency (e.g. FDA EMA MHRA) inspections.
- Knowledge and experience in Good Laboratory Practice (GLP) Good Manufacturing Practice (GMP) and/or Good Clinical Practice (GCP) regulations.
Expected Base Salary Range
$110400 – 139000. The base salary offered will be contingent on assessment of candidate education level background and experience relative to the requirements of the position they are being considered for as well as review of internal equity.
In addition to base salary PTC employees are also eligible for short and longterm incentives. All eligible employees may also enroll in PTC’s medical dental vision and retirement savings plans.
EEO Statement
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals regardless of race color national origin gender age physical characteristics social origin disability religion family status pregnancy sexual orientation gender identity gender expression disability veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
https://lifelancer/jobs/view/b8c849227bbed34a5295760f677800cf
Employment Type
Full Time
Key Skills
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