Our client is a late-stage biopharmaceutical company focused on developing therapies for currently untreatable eye diseases. They have asked us to assist them in their search for a Senior Vice President Technical Operations to oversee all aspects of CMC (Chemistry, Manufacturing, and Controls) and Quality

Major tasks and responsibilities include:

• Ensure that company products are manufactured and delivered in compliance with regulatory requirements and meet the highest quality standards.
• Commercial Readiness and Strategic Planning:
  • Oversee the transformation towards commercial manufacturing readiness, as well as the continuous pursuit of elevating quality across all aspects of GXP.
  • Contribute to the development and implementation of the company's overall strategic plan and transformation towards commercial launch readiness in 2025.
  • Ensure the evolution of performance of manufacturing operations, translating strategy into an executable series of pharmaceutical manufacturing plans and quality control systems to ensure deliverables meet approved budgets.
• CMC Oversight:
  • Provide strategic leadership and oversight for all CMC activities, including process development, scale-up, and commercial manufacturing.
  • Lead assessments and analyses resulting in recommendations for contract manufacturing organization (CMO) qualification and negotiations that are consistent with and supportive of the global strategic plan.
  • Provide CMC perspectives on corporate strategic topics and pipeline expansion.
• Quality Management Oversight:
  • Provide strategic leadership and oversight of the Quality activities and function, including establishing and maintaining a robust Quality Management System (QMS) that ensures compliance with regulatory requirements (e.g., FDA, EMA, PMDA, GxP).
  • Support and provide cross-functional leadership and oversight to inspection-readiness activities led by the Quality function.
  • Instill a culture of quality and data management to assure adherence to compliance requirements.
• Regulatory Compliance:
  • Collaborate with regulatory affairs to ensure timely and successful regulatory submissions and inspections.
  • Direct and oversee the writing and reviewing of CMC sections for INDs, NDAs, and other regulatory submissions.
• Vendor Management:
  • Oversee relationships with contract manufacturing organizations (CMOs) and other external vendors to achieve delivery of objectives and a productive partnership.
• Team Management:
  • Lead and develop a high-performing team, including the Head of Quality and Head of CMC, and instill a culture of quality, integrity, and accountability.
• Budgetary Management:
  • Manage the CMC and Quality budget effectively to achieve operational goals.
  • Oversee the communication of business performance against key performance indicators and associated metrics for production plan adherence, customer service, and inventory management.

We seek candidates with the following qualifications:

• Advanced degree (PhD) in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related pharmaceutical field is required.
• Minimum of 15 years of progressive responsibility in the pharmaceutical/biotech industry, with a primary focus on GMP Commercial.
• Strong experience in Quality Assurance.
• Strong understanding of CMC principles, regulatory requirements, and Quality Assurance and quality systems.
• Proven ability to lead and motivate teams, build consensus, and drive results.
• Ability to successfully lead fast-paced projects with a keen sense of urgency.
• Evidence of "hands-on" experience and expertise.
• Proven and successful track record as a team-player and collaborator in small working environments
• Excellent verbal and written communication skills, with experience translating complex concepts for various audiences.
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit.
• Highest levels of professionalism, confidence, personal values, and ethical standards.
• Able to travel globally up to 20% of the time.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.