• 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

Qualifications:

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).