This position is responsible for maintaining and improving quality systems that support and ensure GMP, GCP, and GLP compliance in both a development and commercial environment.
Collaborate with other members of the Quality organization to assure that all site QA functions are performed meeting ICH Q8, Q9 and Q10, 21CFR parts 210 and 211, and EU Guidelines to GMP. Inform management of significant compliance issues. Ensure quality systems and services are provided for on-site personnel and contractors as appropriate.
The incumbent in this position will establish operational objectives and assignments and may delegate assignments to subordinate staff as well as be involved in recommending policy changes and executing company policies.
This position will work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met.
• Maintain GMP compliance and continuously improve the following Quality Systems:
o Document Management
o Vendor Management
o Internal Auditing
o Deviation/CAPA Management
o Change Control
o Quality Management Review
o Annual Product Review
o Product/Customer Complaints
• Develop and report Quality KPI’s.
• Provide routine GxP training for corporate personnel.
• Provide QA system support during regulatory inspections with document retrieval function, inspection logistics oversight; other functions as required.
• Represent Quality Assurance on cross functional teams as appropriate.
• Provide QA expertise, advice, or assistance to other departments as required.
• Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Other duties as assigned.
• A BS, MS, or PhD in a scientific related field and a minimum of 10 years pharmaceutical industry in a Quality function.
• In-depth knowledge and experience implementing phase appropriate quality systems to achieve GxP compliance.
• Strong and clear understanding of cGMPs, GLPs, and pharmaceutical industry best quality practices.
• Demonstrated leadership in cross-functional and culturally diverse team settings.
• Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship.
• Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met.
• High energy, enthusiasm and excellent leadership and management skills.
• Excellent verbal, written, interpersonal, organizational, and communication skills are necessary.
Drive, desire, motivation
• Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
• Comfortable executing on multiple projects independently.
Fit with GBT culture
• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Excitement about the vision and mission of GBT
• Values-based leadership