Director, Quality Systems

Role Summary

The Director, Quality Systems designs, establishes, maintains, and continually improves the Quality Management System (QMS) governance framework, comprising policies, standards, procedures, people, and technology, to comply with GxP regulatory requirements. The role is expected to develop and execute a strategic plan to ensure the Quality System is fit for purpose, inspection ready, and aligned to corporate objectives.

The Director, Quality Systems collaborates with GMP & GCP Quality leaders and stakeholders across all GxP functions, vendors, and third-party resources to oversee Document Control & Records Management, Training, Supplier Management, and the Audit Program. The role will own the Quality Management Review, and drive standards for Quality metrics, KPIs, and reporting.

Responsibilities

• Build and lead a high performing Quality Systems team through effective workforce management, including recruitment, retention, training, and development of quality staff, to ensure proper skill sets and competencies are consistent with business needs.
• Design, develop, and implement a governance framework that ensures the Quality System is effective, efficient, and extensible.
• Oversee the design, development, implementation, and maintenance of GxP Quality Systems technology, ensuring compliance to regulatory requirements, policies, standards and procedures.
• Plan and develop proactive approaches to implement and coordinate continuous improvement of quality systems. Promote new ways of working to create efficiencies and engagement.
• Define and compile quality performance and compliance reports.
• Lead and/or participate in initiatives as a Quality leadership representative.
• Leverage project and change management techniques to promote adoption of Quality System continuous improvements and a Quality-first culture.

Responsibilities

• Oversee Document Control & Records Management, Training
• Support the definition of Enterprise Content Management strategies
• Provide strategic guidance and leadership to drive the development and implementation of document management practices and systems
• Work with Document Control and Training personnel to develop policies, procedures and controls to ensure training is performed and documents are controlled in compliance with policies and regulations.

Responsibilities

• Oversee Supplier Management, Audit Program
• Work with Supplier Management and Audit Program personnel to develop policies, procedures and controls to ensure compliance with policies and regulations.
• Scale programs to align with business strategy
• Support Inspection readiness programs
• Mature internal and external audit programs

Responsibilities

• Support QA oversight of Validation and Qualification Program:
• Strategize cross-functionally to develop and implement policies, procedures and controls which ensure compliance with 4DMT‚Äôs validation policy and other applicable regulations

Responsibilities

• Other duties as assigned, nothing in this job description restricts management‚Äôs right to assign or reassign duties and responsibilities to this job at any time

Qualifications

• Education ‚Äî Bachelor‚Äôs degree in life sciences, business or related field; advanced degree preferred
• Experience ‚Äî 10+ years of experience in biopharmaceutical industry, preferably in both large and small company environments
• 8+ years experience in Quality Management Systems
• Advanced knowledge in global regulations pertaining to Quality Systems and the ability to interpret, communicate, and implement these requirements.
• Extensive experience participating in regulatory inspections
• Demonstrated project management experience
• Highly proficient using, configuring, and administering GxP QMS and LMS technology platforms
• Proven experience in planning and deployment of GxP computerized systems, including hardware, software, infrastructure and security requirements, SDLC and validation methologies. Experience with industry standard platforms ERP, PLM, LIMS, CTMS, EDC, MES is a plus.
• Advanced experience in project management, business process management, and productivity applications.

Skills

• Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight.
• Ability to think strategically and to influence others
• Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks.
• Excellent verbal and written communication skills; strong interpersonal skills.
• Provide performance reviews, development plans and set goals for department staff in alignment with company goals.

Travel

As needed, less than 5%

Additional Requirements

Base Salary: $195,000/yr - $258,000/yr