Director, Quality Systems

Responsibilities

• Provide strategic roadmap for the Quality Systems organization, including oversight of quality management system, document control, and GxP training groups, oversee personnel performance management, mentoring, and career development.
• Lead and develop teams responsible for document control, GxP training administration, and quality system processes, ensuring effective execution and continuous improvement.
• Acts as Business Process Owner of the QMS.
• Ensure Quality Systems and processes are maintained and modified regularly to ensure best practices.
• Ensure Quality Systems support compliance with applicable FDA, EMA, ICH, GxP, and other relevant regulatory requirements.
• Oversee the document control program, ensuring the effective management, review, approval, issuance, revision, archival, and retrieval of GxP documents and records.
• Oversee the GxP training program, ensuring training curricula, assignment, completion, effectiveness, and compliance requirements are met across the company.
• Collaborate with IT to implement updates/enhancements to the eQMS and ensure effective system support.
• Lead company-wide quality systems projects across various departments.
• Work with GxP functional leaders to implement processes and systems that enable the business to operate effectively.
• Provide process analytics and oversight on a continuous basis to enforce requirements and meet regulations.
• Monitor the entire quality system to ensure that acceptable levels of performance are maintained.
• Manage continuous improvement project as required.
• Establish and report on appropriate metrics and dashboards to monitor overall quality system health and facilitate quality review board and management review.
• Review and approve cGMP records and documents as required.
• Develop and manage goals and corresponding budget in alignment with company vision and goals.
• Work on complex problems that may have implications across functions, apply strong judgment in resolving problems and make recommendations.
• Lead inspection readiness activities related to Quality Systems.
• Lead, mentor, and develop Quality Systems personnel and functional subject matter experts.
• Recruit talent and build a high performing team, mentor, and coach colleagues.

Qualifications

• Bachelor's degree in life sciences with 12+ years’ experience in the biopharmaceutical industry, including at least 7 years of experience leading Quality Systems within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry.
• 5+ years of progressive people-management experience including leading, mentoring, and developing Quality professionals.
• Demonstrated leadership with effective communication skills and an ability to deliver results through teamwork.
• Strong direct experience with Quality Management Systems, including CAPA, Change Control, Deviations, Continuous Improvements and Quality Risk Management.
• Veeva Quality Vault experience preferred.
• Must think critically and be able to make decisions independently, determine appropriate resources for problem resolution, and have strong organizational and planning skills.
• In-depth knowledge of Quality principles, concepts, industry practices, and standards.
• Demonstrated ability to execute strategic and tactical objectives provided by senior leaders both within and outside of Quality.
• Able to effectively communicate vision and expectations to the teams.
• Experience in a global, multi-site, or international GxP environment preferred.