Leads PharMEDium's unified Quality and Regulatory Compliance function that drives the strategic direction, initiative, and accountability required to assure a culture of quality, compliance and operational success within the organization. Reports directly to the President of PharMEDium with a dotted line to AmerisourceBergen's Executive Vice President and General Counsel. Supervises a team of nearly 200 associates across five locations.
PRIMARY DUTIES AND RESPONSIBILITIES:
• Establishes overall quality assurance and regulatory strategy in partnership with senior management. Serves as key advisor to the PharMEDium business management on quality assurance and regulatory matters.
• Serves as the company's primary contact and strategist for regulatory bodies (FDA, DEA and state Boards of Pharmacy). Monitors the regulatory environment and provides senior management with assessments of the impact of new and changing regulations on the business. Proactively manages relationships with regulators, business and operations colleagues, and customers with a view to ensuring appropriate maintenance of quality practices and regulatory standards.
• Oversees the development and implementation of standardized policies, processes, and technology to ensure facilities, manufacturing, packaging, and shipping practices comply with requirements. Implements training programs for direct reports, Quality Assurance staff, and functional/operational staff to assure compliance with current regulations.
• Advises senior management about quality assurance concerns and makes recommendations for improvement. Develops and implements metrics to measure effectiveness of programs.
• Develops and manages capital and operating budgets. Analyzes and controls expenditures to conform to budgetary requirements.
• Determines resources required to meet strategic objectives. Conducts organizational reviews to assure Centers are structured correctly and sufficiently coincide with changes in SOP's. Drives change where necessary.
• Manages a Regulatory and Quality staff of nearly 200 associates in five locations. Responsible for promoting appropriate culture and behaviors among the Quality staff and all other associates across all five locations.
• Establishes standards/metrics to facilitate exponential growth while adhering to quality standards and regulatory guidelines.
• Ability to capitalize on new technologies that can enhance patient safety, streamline processes and/or reduce costs.
• Drives recruitment activity and assures the ongoing professional development of direct reports and the overall company quality/regulatory organization.
• Manage the company R&D activities including approach, methodology and budgets. Works closely with Marketing to align R&D activities with new product initiatives. Is an active partner in the launch of new services.
• Holds oversight responsibility for program management including stability requirements, media fills and product implementation at the facility level.
• Ensures licensures are compliant and current.
• Maintains regulatory files and tracking databases.
• Manages consulting relationships.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
• Bachelor's Degree in Engineering, Science, or related field, Master degree is preferred.
• 15 years in Quality/Regulatory environment, preferably aseptic device and drug manufacturing.
• A demonstrated ability to lead people and get results through others.
• Ability to positively influence groups to embrace a common philosophy.
• Computer proficiency.
• Excellent leadership skills, including ability to effectively manage associates in multiple locations.
• Excellent interpersonal/communication skills, interpersonal agility and self-awareness. Must have confidence when communicating with a variety of constituents including executive management, regulatory agencies and outside organizations as well as field staff in outsourcing facilities.
• Must possess strong analytical ability coupled with strong decision making skills.
• Expert technical, regulatory, compliance and problem solving skills.
• Experienced at process design.
• Must be able to escalate issues in the face of competing priorities.
• Adept at building organizations in a high growth environment.
• Employs an entrepreneurial spirit that challenges the norm - not afraid to think outside the box.
• Self-motivated with exceptional follow through.
• Proven ability to condense diverse, complex issues and concepts into a crisp, clear message for PharMEDium Regulatory/Quality staff.
A little about us:
Where knowledge, reach and partnership shape healthcare delivery.