Job Summary This role serves as the primary Subject Matter Expert (SME) for all regulatory and compliance matters involving 503B Outsourcing Facilities. You will oversee sterile drug manufacturing using aseptic processing, wholesale drug distribution, and comprehensive compliance activities. Job Duties & Responsibilities Develop, implement, and maintain standardized processes in the Quality Management System to ensure compliance with relevant standards and regulations Oversee management, review, and approval of Quality Event investigations from initiation to closure for complaints, deviations, non-conformances, CAPAs, and SCARs to ensure timely completion, and ensure timely completion of associated investigations, appropriate root cause analysis, and effective implementation of corrective/preventive actions Oversee, lead, and manage quality system related meetings including management review Lead and/or support risk management initiatives by identifying, addressing, and escalating risks/issues as necessary Lead and support continuous improvement initiatives to enhance quality system processes Oversee and manage and use of quality system software(s) Lead and provide organizational training and guidance on quality standards, processes, procedures, and corrective/preventive actions Oversee management and coordination of training requirements/assignments Manage the quality data collection and reporting processes, including tracking and analyzing key performance indicators (KPIs) Oversee supplier management program to ensure appropriate qualification and maintenance of the approved supplier list Support documentation requests from regulatory affairs department to support regulatory submissions (e.g. PMA supplements, 510(k) submissions) Manage internal audit program and schedule to assess and maintain compliance of quality management system with regulations/standards, and internal organizational policies and standard operating procedures Direct and lead internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and standard operating procedures Develop and maintain professional working relationships with current and potential customers, consultants, suppliers, and vendors Establish and execute continuing education strategy for department Integrate shared leadership and foster collaboration across multi-disciplinary teams Maintains company compliance and a working knowledge of

FDA 503B

guidance, State Board of Pharmacy(s), ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures Manage direct reports Provide constructive feedback and guidance to develop leadership in direct reports and department management Establish and monitor objective annual goals for direct reports Conduct performance reviews and establish performance improvement plans as needed Recruit, interview, and select personnel for hire Maintain acceptable attendance and punctuality for scheduled work hours and meetings Ensure completion of assigned tasks and responsibilities within defined timeframes Maintain flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary Perform other duties as assigned Experience Knowledge of FDA's Quality System Regulations Ability to manage multiple complex problems simultaneously Ability to be flexible in changing daily workload priorities as directed Ability to coordinate and synchronize multiple projects Ability to conduct a significant amount of planning activities for self and others Ability to take initiative and make decisions within company/departmental guidelines Ability to thrive under challenging deadlines and in an energetic environment Ability to work independently and in a team environment Excellent attention to detail and organization Excellent written and verbal communication Highest level of ethics and integrity Ability to lead and motivate the right behaviors Strong technical writing Effective project management Proficiency in

Microsoft Office Pay:

$130,000.00 - $150,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person