Vice President, Regulatory and Quality Assurance - Voyager Therapeutics : Job Details

Vice President, Regulatory and Quality Assurance

Lexington, MA

About Voyager TherapeuticsVoyager Therapeutics, Inc.(Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer's disease, Friedreich's ataxia, Parkinson's disease, amyotrophic lateral sclerosis (ALS), and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease;Novartis Pharma AG; and Neurocrine Biosciences, Inc. For more information, visit .

Voyager Therapeutics is a registered trademark, and TRACER is a trademark, of Voyager Therapeutics, Inc.

Job Summary:

The Vice President, Regulatory Affairs and Quality Assurance provides strategic leadership for all regulatory and quality activities across preclinical, clinical and manufacturing in support of the scientific pipeline.

Reporting to Toby Ferguson, Voyager's Chief Medical Officer, the VP Regulatory & Quality is responsible for devising and implementing regulatory strategy and providing leadership oversight for all regulatory activities across all areas of development. This role is also responsible for developing and maintaining Quality systems to support approval of products and in compliance with GxP regulatory requirements. The leader plays a key role in fostering strong relationships and advocacy with FDA and other international regulatory authorities.

Position Specific Responsibilities:

• Formulate a comprehensive and compelling development strategy and drive the execution of tactical plans to achieve Voyager's portfolio-wide goals.
• Provide direct regulatory oversight to all applicable pre-clinical, clinical and CMC activities.
• Oversee all globally regulatory submissions to advance and maximize success of the portfolio. This includes ensuring that direct reports have defined, developed, and clearly communicated global strategies and risks for all development programs.
• Proactively identify corporate or program regulatory or quality risks, bring awareness to potential safety and compliance issues and provide creative solutions and strategies to overcome development hurdles, including risk mitigation.
• Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to Voyager's leaders and drive interactions between the Company and regulatory authorities.
• Establish and lead Quality Review Board to monitor, investigate and ensure resolution of quality issues. Report on quality system performance and compliance status to Senior Management and implement improvements as necessary.
• Oversee all Quality activities and systems across pre-clinical, clinical and manufacturing, including the following:
  • Final Release of product, including use of QPs for ex-US release.
  • Quality oversight of external and internal GMP manufacturing and QC.
  • GxP compliance; including Training, Deviation and change control.
  • CRO and CDMO Quality Oversight including qualification and audits.
  • Internal auditing and inspection readiness
• Develop and design robust regulatory and quality structures, processes, and procedures.
• Present and communicate with key internal and external stakeholders regarding regulatory or quality strategy and relevant issues.
• Actively participate in company governance committees as required.
• Track project Regulatory and Quality activities, deliverables, and completion relative to budgets and Company objectives
• Leadership and development of the Quality and Regulatory organizations.

Specialized Knowledge & Skills:

• Ability to provide innovative strategies in complex regulatory landscapes preferred.
• In-depth understanding of drug development and product commercialization preferred.
• Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders at the executive level.
• Leadership and management skills to grow and manage a high performing Quality and Regulatory organizations.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
• Excellent oral and written communications skills with the ability to compellingly influence.
• Demonstrated ability to build cross-functional relationships and work collaboratively is a must.
• Proven sense of urgency in managing project teams to meet goals and deadlines is required.

Requirements:

• BS degree focusing on life sciences or related area; an advanced degree e., MS, PharmD, PhD, MD) is preferred.
• Minimum 10 years of progressive experience in Regulatory Affairs strategy within the pharmaceutical industry.

Experience :

• Demonstrated enterprise leader with a minimum of 5 years functional leadership and people management.
• Experience leading, designing, writing, and submitting regulatory INDS with BLA filing experience preferred. Previous product approval preferred.
• Previous interaction with CBER strongly preferred.
• Global filing experience preferred.
• Experience in neurology and gene therapy areas preferred.

Please no agency submissions. Voyager will not accept nor respond to unsolicited resumes from staffing firms.

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