[Hiring] Executive Director, Quality- Vendor & Inspection Management @ARAVAS INC

Role Description

The Executive Director, Quality is responsible for a broad range of disciplines critical to a high-performing Quality Unit. This position requires both strategic vision and hands-on execution across Vendor Lifecycle Management, Inspection Management (IM), Quality Risk Management (QRM), Computer System Validation (CSV), and Data Integrity (DI).

This role reports to the Head of Quality and is a member of the Quality Leadership Team. The primary focus of this role is to develop and execute strategy for Savara's end-to-end vendor lifecycle management, ensuring appropriate oversight at each vendor and maintaining continuous inspection readiness across key sites. When regulatory inspections arise (both at vendor sites and Savara), this leader coordinates all inspection management activities. The role also delivers GxP training across clinical, CMC, and post-marketing functions, and leads quality risk assessments accordingly.

The successful candidate will continuously evolve internal processes to identify and manage compliance risks, and ensure that issues are escalated to senior management in a timely and appropriate manner. Building strong, trusted relationships with both internal teams and external stakeholders is essential to success in this position.

Core Responsibilities

• Vendor Lifecycle Management
  • Define and execute the strategic plan for maintaining GxP vendor lifecycle management, including onboarding, audits, quality agreements, change notifications, inspection readiness, and offboarding across all GxP vendors.
  • Partner with both Clinical and CMC partners to support external vendors during audits and inspections.
  • Collaborate with stakeholders such as Global Technical Operations and Supply Chain, Clinical Operations, Clinical Development, and Regulatory Affairs to ensure both Savara internal and external (vendor) inspection preparedness, conduct compliance assessments, identify and mitigate compliance gaps, and offer guidance related to GxP processes.
  • Assess proposed corrective or preventive actions in response to audit or inspection findings, track and report item closures, and escalate areas of risk or concern in a timely manner.
  • Implement a risk-based approach strategy for both vendor lifecycle and inspection readiness.
• Inspection Management (IM)
  • Lead the inspection management program by partnering with inspection readiness leads, the Head of Quality Systems, and others to manage internal logistics for GxP inspections and audits at Savara.
  • Maintain and update inspection opening presentation materials and create a continuous improvement process for Inspection Management processes and activities, including policies, procedures, and training.
  • Provide both materials and company-wide training on GxP inspection-related topics.
  • Develop, track, and report compliance and inspection metrics, and escalate trends or significant findings to company management in a timely manner.
• Quality Risk Management (QRM)
  • Implement a pragmatic Quality Risk Management (QRM) Program using appropriate risk management principles and a risk-based approach, and provide training as necessary.
  • Work with key Savara stakeholders to integrate QRM approach into key processes as required.
  • Monitor current regulatory requirements, inform stakeholders of potential impact from new regulations or guidances, and perform gap assessments as necessary.
• Computer System Validation (CSV)
  • Drive and monitor a Computer System Validation (CSV) program ensuring that systems used at Savara and at our vendors meet Health Authority regulations.
  • Ensure CSV activities are aligned with current regulatory expectations and data integrity requirements, and maintain oversight of validation documentation and lifecycle management.
• Data Integrity (DI)
  • Partner with appropriate teams to implement a Data Integrity (DI) strategy across all GxP areas.
  • Establish and maintain DI standards, training, and oversight mechanisms to ensure compliance with applicable Health Authority regulations and guidances.
• Leadership & Cross-Functional Collaboration
  • Lead cross-functional teams, mentor staff, and manage, coach, and grow direct reports as applicable.
  • Other duties and projects as assigned.

Qualifications

• 12+ years of global quality/regulatory compliance in pharma/biotech, with a hands-on role in quality operations/quality systems.
• 5+ years Supervisory experience a plus.
• Advanced degree in a related discipline a plus.
• GxP Auditor certifications a plus.
• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations (CFR) related to GxP, ICH Guidelines, and Health Authority requirements.
• Proven ability to manage external quality issues through a vendor management program.
• Experience in the biotech or pharmaceutical industry influencing and/or managing Vendors during inspections.
• Experience with managing the FDA's Bioresearch Monitoring (BIMO) program inspections is preferred.
• Proven experience with implementing a Quality Risk Management program, defining metrics and (preferred) defending the program to Health Authorities.
• Working knowledge of the requirements of data integrity to provide training, and integrate into inspection management, particularly in relation to Clinical trials and GDPR.
• Experience in a virtual manufacturing environment; knowledge of large molecule and biologics is preferred.
• Excellent verbal and written communication skills, ability to work with cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
• Position requires a highly diplomatic, calming demeanor, tactful and detail-oriented individual with excellent critical reasoning skills.
• Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
• Withholds judgment to address conflict in a positive manner by acknowledging dissenting opinions and identifying options to achieve an equitable solution.
• Models team spirit, culture, and ethics.
• Demonstrates a high level of independent quality judgment and acumen, comfortable with ambiguity and a pragmatic approach to problem solving.
• Develops talent through mentoring and coaching.
• International/global experience preferred.
• Understands technical information related to equipment, processes, and regulatory expectations.
• Uses broad expertise or unique knowledge and skills to drive and deliver on company core objectives, and achieve goals with measurable impact and outcomes.

Work Schedule and Location

• This role is remote within the US and requires the ability to work US Eastern Time Zone.
• Occasional travel to the corporate office outside of Philadelphia, PA and vendor locations domestically and internationally will be required.

Benefits

• Medical, dental, and vision coverage.
• Flexible Spending Account for health care and dependent care expenses and Health Savings Account.
• Paid time off and paid holidays, including Dec 24-Jan 1.
• Paid parental leave.
• 401(k) with highly competitive match.
• Life, AD&D, STD and LTD insurance coverage.
• Other supplemental insurance programs.

Company Description

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.