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Manager, Quality Assurance – GxP (GVP)
@PTC Therapeutics, Inc.
[Hiring] Manager, Quality Assurance – GxP (GVP) @PTC Therapeutics, Inc.
Mar 25, 2025 - PTC Therapeutics, Inc. is hiring a remote Manager, Quality Assurance – GxP (GVP). 💸 Salary: unspecified. 📍Location: Ireland.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
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 post-marketed products.
- Responsible for QA oversight and support of pharmacovigilance function.
- Engage and collaborate with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs).
- Assist in inspection readiness activities.
- Support and/or conduct internal and external/vendor GVP audits of pharmacovigilance processes, safety vendors, distributors, market research vendors, patient support programs, etc.
- Support adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs).
Qualifications
- Bachelor’s degree in scientific discipline.
- 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, third-party vendors.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment.
- Analytical thinker with excellent problem-solving 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.
Requirements
- Special knowledge or skills and/or licenses or certificates preferred.
- 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.
- Travel requirements: Up to 30%.
Company Description
PTC Therapeutics is a global biopharmaceutical company founded in 1998 initially focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes.
- Our technology platforms have expanded from foundational scientific expertise in RNA mechanisms to include multiple approaches including gene therapy.
- Focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders.
- Our internally discovered pipeline addresses multiple therapeutic areas, including neuromuscular disorders, oncology, and metabolic diseases.
- Our mission is to provide access to best-in-class treatments for rare disease patients who have little to no treatment options.
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| 📍 | Be aware of the location restriction for this remote position: Ireland |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
QA
QA
|
Salary
💸
unspecified
|
Remote
Location
Ireland
|
|
Job Type
full-time
|
Posted
Mar 25, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: Ireland |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
