Myonex, Inc. Associate Director, Quality Share in Horsham, Pennsylvania
Reference #: 852074 Job Description
Primary Role: The Associate Director of Quality is responsible for leading the US Quality team to ensure that US Myonex sites operate in compliance with local regulatory requirements as well as customer expectations. This role also works closely with our sister sites on a global basis. This role works closely with overall operations, warehouse, business development, project management and procurement teams, and external key stakeholders, provides tactical and day-to-day direction in the completion of all aspects of the quality management system and ensuring that the company maintains GMP and GDP compliance. Mentoring, training, and guiding all team members is a critical part of this role. Duties: * Under the direction of the Vice President, Global Quality, closely collaborates with appropriate business/operations areas to ensure that effective and robust quality systems and processes are in place to support Myonex business. * Provides technical and quality expertise and is a resource for Quality Assurance team members in the completion of day-to-day quality tasks and initiatives, including but not limited to maintaining the Quality Management System and supporting operational activities including receipt/storage/distribution and packaging and labeling of drug product and ancillary supplies. * Supports customer qualification of Myonex, including hosting customer audits and training qualified backups for this activity as well as negotiating Quality and Technical Agreements. * Partners with quality leaders in sister locations and other regions to achieve harmonization of quality processes across all Myonex entities. * Develops and manages a collection of metrics and KPIs to assess the level of compliance and targets areas for improvement and ensures alignment across all sister sites. * Supports the implementation of the DSCSA 2023 and facilitates serialization implementation to comply with the required regulations. * Periodically reviews quality systems and practices for improved efficiency and to ensure compliance. * Provides individual and company-wide training and education with quality topics as identified. * Reviews and approves controlled documents. * Oversees facility change control, expansion, and qualification activities. * Supports and oversees the implementation of automated systems and system upgrades as identified by the business. * Support process improvement activities to streamline and minimize/eliminate waste using Six Sigma methodologies. * Supports DEA, GDP and GMP related regulatory activities, including hosting regulatory inspections. * Manages the US Quality Assurance staff including mentoring direct reports, development of team members, and participating in sourcing resources and hiring Quality team members. * Embody the Myonex Core Values: Consistently finds ways to live out the Myonex core values of: * Be a Great Team Player * Be Customer Focused * Learn & Grow * Find a Way
Experience and Skills
Education & Experience: BS in science or technology or equivalent work experience. A minimum of 12 years' experience in managing a team of people in a relevant process intensive, regulated environment required. Pharmaceutical industry, pharmaceutical contract service organization or pharmaceutical distribution experience is required. Skills/Qualifications: * Strong knowledge of regulatory requirements including Good Manufacturing Practice, Good Distribution Practice, and Wholesale Distribution regulations and the ability to apply them to common sense, robust business scenarios. * Demonstrated knowledge of continuous improvement and project management methodologies. * Ability to work with cross-functional/disciplinary teams. * Demonstrated leadership leading successful Quality teams and implementing/maintaining a strong culture of quality. * Thorough understanding of storage, secondary packaging/labeling, and distribution of commercial pharm ceutical products and investigational medicinal products. * Skilled in: MS Office (Outlook, Word, Excel, PowerPoint). Experience using ERP and electronic QMS systems. * Ability to: Manage multiple responsibilities simultaneously and adapt to changing priorities. * Coach, mentor and train team members for development opportunities, optimal performance, and compliance. * Results oriented, confident, self-motivated, and driven with high energy. * Good analytical abilities and problem-solving techniques.