ProClinical is recruiting for a top, permanent position as a Director or Senior Director of QA and Compliance based in Gaithersburg, MD, for our client. A clinical-stage vaccine company – creating tomorrow’s vaccines today – they seek to attract, develop, and retain talented people who share their passion for science, medicine, and human health. They foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. They are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.
The Senior Director or Director of QA Development and Compliance will develop, maintain, and improve upon global compliance strategies by contributing data, analysis, and recommendations to strategic thinking and direction.
- Develop global compliance operational strategies by establishing critical quality and operational metrics and measurements; conducting trend analysis; system design and implementation.
- Assure GXP operations are executed in compliance with applicable guidelines and regulations through quality risk management and risk assessments.
- Educate and drive a quality risk management culture and manage/escalate the company's risk register and visibility to Sr. Leadership.
- Review and approve of development reports, qualification reports, validation protocols, reports, and amendments, change controls, CAPAs and deviations.
- Assure that effective auditing functions are in place to address company requirements for vendors, customers, and outside contract organizations.
- Quality agreement construction, negotiation and approval.
- Provide mentorship, leadership, and prioritization to staff to execute their respective duties.
- Builds and promote a culture of operational excellence within the quality unit.
- Stays current and is an internal company subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
- Effectively cooperates with departments across the company to analyze and resolve technical issues in accordance appropriate quality standards.
- Supports regulatory inspections as necessary.
Skills And Requirements
- Bachelor's degree in biological science.
- 15+ years’ experience in pharmaceutical, biologics and/or vaccine manufacturing.
- 10+ years’ supervisory experience.
- Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, including PPQ.
- Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and Eudralex Vol 4), including regulatory inspection or support experience is preferred.
- Experience in validation of IS systems.
- Excellent multi-tasking, analytical, organizational and leadership skills.
- Excellent problem-solving skills.
- Ability to communicate clearly and effectively with all levels of the organization.
- Skilled with Microsoft Office; adaptable to new systems and technologies.
- Ability to effectively build and maintain relationships with across the organization in order to effectively solve problems.
- Ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
- Ability to enable and drive change while being focused on internal and external customers.
- Excellent communication skills both verbal and written; and with various organizational levels internally and externally.
- Experience in validation in process, cleaning, equipment and utilities.