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 post-marketed products.
The incumbent is responsible for QA oversight and support of pharmacovigilance function. This involves engaging and collaborating 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) 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.Job Description:
Responsibilities:
- Partners with Pharmacovigilance function to ensure GVP compliance. Assists in identifying and communicating pharmacovigilance-related 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.
Qualifications:
- 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, third-party vendors.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- 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.
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%
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.
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