Description

Reporting to the Chief Regulatory Officer, the Vice President, Quality is responsible for providing the strategic leadership and management of the company’s Quality organization. This individual will ensure that Pliant maintains a culture of quality and compliance with all regulatory requirements and will focus on optimizing quality and reducing risk. The successful candidate will be a highly experienced and innovative executive Quality leader who will be responsible for expanding, leading, and inspiring a Quality team that promotes a best in-class Quality organization to enable the robust commercialization of our advancing clinical therapies. This leader will be accountable for building and shaping the quality organization aligned with the growth of the company and productivity of the portfolio. The VP, Quality will have end-to-end Quality responsibilities inclusive of leading GLP, GCP, GVP and GMP functions.

Responsibilities

• Designs and executes global quality strategies from end to end.
• Collaborates with internal functions and aligns goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, GVP and GLP compliance and realization of other value-added guidelines and best practices.
• Directs and oversees the quality planning and execution processes.
• Ensures that the quality policies and objectives are understood, implemented, and maintained at all levels of the organization.
• Assures that the appropriate suite of Standard Operating Procedures is in place and optimally maintained to support critical drug development activities as well as our vendor relationships with external CRO or CMOs.
• Ensures quality systems and processes are designed to be appropriate for development, manufacture, testing and release, and distribution of quality product, and be consistent with the global quality strategy and meet all relevant regulatory requirements including federal, state, and international regulations, applicable standards and guidance.
• Ensures a robust and risk-based audit program is successfully realized throughout our vendor network.
• Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our CMO’s, CRO’s, partners and suppliers.
• Develops key quality system metrics and process indicators to proactively identify and address quality systems or product issues.
• Leads Quality Management Review and assures that there are no significant interruptions to the business due to quality or compliance issues.
• Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes and appropriately structured quality operations.
• Interfaces directly with the FDA, EMEA, and other regulatory authorities ensuring the company is appropriately represented in communications with the health authorities.
• Develops and leads a high performing Quality organization through performance management, team development, coaching and mentoring.

Qualifications:

• Bachelor’s degree or advanced degree (preferred) in a scientific field
• Minimum of 15 years quality experience in a biotech/pharma environment with at least 5-7 years as functional head of quality
• Experience in late-stage and commercial stage companies
• Multidiscipline expertise and experience in a GCP and GVP as well as familiarity with non-Clinical requirements and responsibilities
• Excellent working knowledge, understanding and experience with the practical implementation of FDA and EMEA (or equivalent) regulations and guidelines in GLP, GCP and GXP environments
• Successful experience with FDA, EMA, APAC (China NMPA, Japan PMDA) and/or equivalent regulatory inspections, audits and/or due diligence
• Experience contributing to successful NDA submissions
• Experience managing, overseeing and working with vendors
• Quality auditing experience a plus
• Established leader in the pharmaceutical industry with clear and proven capability developing, coaching, communicating, leading, managing and inspiring within and beyond Quality organizations and efforts
• Excellent oral and written communication skills to all employment levels and external partners, suppliers and industry organizations
• Proven experience in building and leading a highly performing quality team

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).