PMV Pharmaceuticals is looking for an individual to join the company as Sr. Manager, Quality Assurance (GCP) Contractor. This role will be focused on ensuring GCP compliance, providing day to day support to Quality Assurance and project team activities. This candidate will conduct and/or participate in all GCP QA audit programs which includes both internal & external GCP audits. This individual will support the quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. This is a full-time hybrid position based out of Princeton, NJ.
Responsibilities
- Leads and supports GCP QA audit activities including internal and external audits of CROs, vendors, system, facility, and investigator sites.
- Provide GCP compliance expertise / leadership and work effectively with PMV staff to manage the quality program for assigned programs.
- Collaborate on day to day activities with clinical operations including document review such as protocols, SOPs, and other such documents.
- Takes a lead role in regulatory inspectional activities as audit lead or triage management.
- Support/lead the development of audit plans for clinical programs and quality agreements with vendors/partners.
- Support risk based management actiivties including deviation and CAPA management and the generation of clinical quality metrics.
- Support the creation and management of GxP and departmental SOPs throughout the PMV organization.
- Provide QA support for validation efforts for electronic databases that will be utilized for regulatory or quality assurance purposes.
- A minimum of 20% Travel / Field work is required to domestic and international locations in a lead / support role with consultants, partners, subject matter experts, inspections, etc.
- Perform other duties, as required.
Qualifications
- In depth knowledge of GCP regulations and guidances
- Knowledge of GLP and PV, including their application in quality systems, quality assurance, quality control, audits and health authority inspections
- Minimum of 5 years of work experience in the pharmaceutical/biotech industry with direct experience supporting and performing GCP QA onsite and remote audits, globally.
- Hands-on experience in regulatory inspections, investigator site audits, vendor audits/qualifications, internal audits and document audits is preferred.
- Experience in the use of electronic quality management systems such as Veeva.
- Oncology experience preferred
- Knowledge of risk management approaches in a clinical environment
- Ability to work both independently with minimal direction and within project teams, etc. supporting multiple projects simultaneously.
- Bachelor's degree in Life/Health Sciences or equivalent work experience
- Strong verbal / written communication and presentation skills.
- Ability to work well in a deadline-driven environment.
- Excellent computer skills; use of Microsoft Office (Excel, Word, Microsoft Project, PowerPoint).