Manager, Quality Assurance - GCP (Remote) Job at PTC THERAPEUTICS
Job Description Summary:
The Manager, Quality Assurance - Good Clinical Practice (GCP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Clinical Practice (GCP) compliance for development products.
The incumbent is responsible for QA oversight and support of clinical studies in all phases of development. 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.
He/she will assist in inspection readiness activities.
The incumbent will support and/or conduct internal and external GCP audits of investigator sites, vendors, clinical study reports, investigator brochures, and submission documents, etc.
Job Description:
Responsibilities:
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Partners with Clinical Development/Operations and actively participates in clinical study teams to ensure GCP compliance. Assists in identifying and communicating clinical trial-related risks and opportunities for process improvement. Reviews study-related documents and plans.
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Performs internal and external audits as assigned to assure compliance with GCP regulations and guidelines.
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Communicates audit results to internal stakeholders and writes audit report.
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Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs).
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Participates in regulatory authority inspections and assists with GxP inspection readiness activities.
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Maintains effective relationships with colleagues and other departments by working collaboratively to deliver high quality service to the organization.
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Ensures appropriate and timely escalation of quality issues, including issues of significant deviation with projects to QA Management and makes appropriate recommendations for correction and improvement as may be necessary.
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Engages in quality system continuous improvement initiatives to enforce the quality culture.
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Performs other tasks and assignments as needed and specified by management.
Qualifications:
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Bachelor’s degree in a scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment.
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Detailed knowledge and understanding of GCP regulations.
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Demonstrated experience leading and/or conducting QA audits.
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Demonstrated experience developing and executing risk-based audit plans.
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Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors.
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Ability to influence without direct authority.
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Proficiency with Microsoft Office.
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Excellent verbal and written communication and skills.
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Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
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Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
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Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.
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Experience writing and reviewing SOPs preferred.
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Clinical lab experience preferred.
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Registered GxP Quality Assurance Certifications preferred.
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Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections preferred.
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Knowledge and experience in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and/or Good Pharmacovigilance Practice (GVP) regulations preferred.
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Up to 30% travel
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Remote position
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
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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