Senior Director, Quality Assurance

Reporting to VP of Quality Assurance (GXP) is responsible for the strategic development and operational management of Pliant's Quality Assurance program and is accountable for the execution and administration of the GXP Quality Systems to support CMC operations and preclinical studies in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. The scope of this role includes ensuring Good Manufacturing Processes (GMP) and Good Laboratory Practices (GLP) compliance and quality systems at Pliant and its vendors. This position requires expertise in current GMP and GLP and relevant regulations. This role is accountable for ensuring that vendors and laboratories are compliant with global regulations, prepared for potential Regulatory Audits and Inspections and that the appropriate processes, systems, and activities are in place and performed to protect product quality and data integrity. The role will build an internal QA (GMP/GLP) team and relationships with external consultants/contractors, as necessary to support QA (GMP/GLP) activities and responsibilities.

The ideal candidate will have extensive experience leading GMP/GLP Quality Assurance activities and deep understanding and demonstrated working knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, and other regulations that govern GMP/GLP compliance during clinical development and commercialization of drug candidates. QA (GMP/GLP) team will be accountable for all aspects of product quality throughout development, both internally and in collaboration with CMOs and testing laboratories. The ideal candidate will have a proven track record of providing Quality Assurance support for regulatory submissions of quality related sections resulting in world-wide marketing approvals for drug products.  This role is required to work on site.

• Lead the QA GMP/GLP team in managing all GMP/GLP related QA activities
• Lead the QA GMP/GLP team in development, implementation, and management of Pliant GMP/GLP quality and compliance systems and policies, SOPs, QA processes and procedures
• Ensure good communication and decision making at the appropriate levels for quality GMP/GLP related topics
• Oversee the planning and conduct internal and external audits
• Manage internal and regulatory agency on GMP/GLP related inspections
• Develop proactive and practical approaches and provide strategic direction to implement quality standards and procedures
• Lead GMP/GLP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; provide oversight of appropriate CAPAs associated with deviations and investigations
• Ensure Technical Operations and vendor activities are compliant with cGMP, FDA, ICH, EMA regulations and guidelines and industry standards
• Stay abreast of industry developments - forthcoming regulations, guidance, best practices, etc., training, and mentoring staff on global GMP/GLP regulations and guidance
• Identify quality improvement needs and opportunities and assure that appropriate personnel address the issues. Assure corrective actions are implemented
• Advise Company's Executive Team on the implications and risks related to key Quality issues and important strategic decisions, keeping all posted, on a timely basis

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• Advanced degree, ideally in life sciences related field with at least 12+ years of experience in positions of substantial management responsibility within Quality Assurance
• Strong working knowledge of global GMP/GLP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct
• Skilled at preparing, negotiating and managing phase-appropriate quality agreements with Pliant GMP/GLP vendors
• Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation
• Proven track record in establishing a quality organization and managing GMP/GCP Quality staff.
• Demonstrated success supporting cross-functional teams and managing direct reports
• Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific and operations leaders and staff
• Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections
• Experience with documentation systems, document review and auditing responsibilities
• Ability to effectively present information to top management, and/or boards of directors
• Demonstrated ability in setting successful quality strategies and building and leading the function
• Knowledge of relevant regulations, including FDA, EMEA, ICH
• Ability to think strategically and translate into action
• Available to travel if/when needed

Knowledge, Skills, and Abilities:

• Small company / pre-commercial to commercialization stage experience desirable
• Strong collaboration and cross-functional team participation skills
• Preference for applying a solutions-oriented mindset and approach to resolving complex quality issues
• Effective leader of others and ability to mentor/develop team members
• High self-awareness and commitment to iterative learning and development
• Effective communicator, verbal and written, strong interpersonal skills
• Accuracy and attention to details

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

The annual base salary for this role is $265,000 - $275,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant's compensation package also includes benefits, equity, and annual target bonus for fulltime positions.