Director, Quality Systems

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4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

General 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.

MAJOR DUTIES & RESPONSIBILITIES:

Quality System Governance

• 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.
  
  

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.
  
  

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
  
  

Support QA oversight of Validation and Qualification Program:

• Strategize cross-functionally to develop and implement policies, procedures and controls which ensure compliance with 4DMT’s validation policy and other applicable regulations
  
  

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

QUALIFICATIONS:

Education

• Bachelor’s degree in life sciences, business or related field; advanced degree preferred
  
  

Experience:

• 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%

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

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities