Senior Manager, Quality Assurance- Vendor Management
PTC Therapeutics, Inc.
18 days ago
Remote friendly (New Jersey, United States)
United States
Operations
Job Description Summary
The Senior Manager Quality Assurance (QA) - Vendor Management manages and supports PTC’s risk-based vendor qualification program for GxP (GMP, GDP, GCP, GLP, GVP) vendors, suppliers, and service providers and PTC’s Quality Technical Agreement (QTA) system. Supports the establishment, management, and continuous improvement of Vendor Management QA procedures/processes; works cross-functionally on quality issues; supports adherence to regulatory requirements and company SOPs.
Responsibilities
- Lead minor projects; support major projects; facilitate milestone tracking; develop/implement/improve Vendor Management QA functions ensuring GxP compliance.
- Manage vendor processes: new/revised/discontinued requests, qualification program, questionnaires, risk assessments, approvals, Approved Vendor List (AVL), periodic review/requalification, risk management, metrics, health evaluations, and vendor issue escalation/resolution.
- Administer QTA system.
- Ensure documentation is compliant and available for inspection/submission.
- Assess/approve new or changed vendors in Ariba for GxP qualification; ensure subsequent requests in Veeva.
- Create/revise SAP Source Lists consistent with AVL.
- Support change management, deviations/investigations, batch recalls; support GMP/GDP audits of CMOs, contract testing labs, and distributors.
- Review/approve quality documentation and functional area procedures; support continuous improvement of quality systems and GMP practices.
- Participate in regulatory inspections and support audit responses.
- Perform other tasks as assigned.
Qualifications
- Bachelor’s degree in a scientific discipline and 7+ years progressive pharmaceutical GxP QA/QC/Compliance experience with prior management experience.
- Proficiency in QA principles and vendor management QA activities.
- Knowledge of regulations and regulatory sources; detailed understanding of GMP, GDP and/or GCP.
- Understanding of production/laboratory systems; international quality systems.
- Proficiency with Microsoft Office.
- Excellent verbal/written communication; independent and collaborative work in a fast-paced matrix environment.
- Analytical/problem-solving skills; ability to adapt to changing priorities and deadlines; strong planning/organization/time management.
Expected Base Salary Range
$139,700 – $175,800. Eligible for short- and long-term incentives and medical/dental/vision and retirement savings plans.
The Senior Manager Quality Assurance (QA) - Vendor Management manages and supports PTC’s risk-based vendor qualification program for GxP (GMP, GDP, GCP, GLP, GVP) vendors, suppliers, and service providers and PTC’s Quality Technical Agreement (QTA) system. Supports the establishment, management, and continuous improvement of Vendor Management QA procedures/processes; works cross-functionally on quality issues; supports adherence to regulatory requirements and company SOPs.
Responsibilities
- Lead minor projects; support major projects; facilitate milestone tracking; develop/implement/improve Vendor Management QA functions ensuring GxP compliance.
- Manage vendor processes: new/revised/discontinued requests, qualification program, questionnaires, risk assessments, approvals, Approved Vendor List (AVL), periodic review/requalification, risk management, metrics, health evaluations, and vendor issue escalation/resolution.
- Administer QTA system.
- Ensure documentation is compliant and available for inspection/submission.
- Assess/approve new or changed vendors in Ariba for GxP qualification; ensure subsequent requests in Veeva.
- Create/revise SAP Source Lists consistent with AVL.
- Support change management, deviations/investigations, batch recalls; support GMP/GDP audits of CMOs, contract testing labs, and distributors.
- Review/approve quality documentation and functional area procedures; support continuous improvement of quality systems and GMP practices.
- Participate in regulatory inspections and support audit responses.
- Perform other tasks as assigned.
Qualifications
- Bachelor’s degree in a scientific discipline and 7+ years progressive pharmaceutical GxP QA/QC/Compliance experience with prior management experience.
- Proficiency in QA principles and vendor management QA activities.
- Knowledge of regulations and regulatory sources; detailed understanding of GMP, GDP and/or GCP.
- Understanding of production/laboratory systems; international quality systems.
- Proficiency with Microsoft Office.
- Excellent verbal/written communication; independent and collaborative work in a fast-paced matrix environment.
- Analytical/problem-solving skills; ability to adapt to changing priorities and deadlines; strong planning/organization/time management.
Expected Base Salary Range
$139,700 – $175,800. Eligible for short- and long-term incentives and medical/dental/vision and retirement savings plans.