Headquartered in Phoenix, AZ, Avella Specialty Pharmacy is one of the largest specialty pharmacies in the country and primary engaged in serving patients, hospitals, ambulatory surgery centers and providers through four platforms – specialty pharmaceutical dispensing, 340B contract pharmacy, 503B outsourcing, and 503A compounding.
Avella’s 503B outsourcing operations are conducted in two locations - Houston, TX and Phoenix, AZ. The 503B outsourcing business unit is engaged in the manufacturing of compounded sterile preparations (CSPs) for use in hospitals, ambulatory surgery centers and provider practices nationwide.
The Vice President, Pharmaceutical Manufacturing Operations, will be based in Houston, TX, and serves as a business partner to the Avella 503B Executive Team and will report to the Chief Operating Officer. The VP will serve as a business partner to the organization and act as the agent responsible for executing and driving progress against all of the organizations’ mutli-site, multi-product, 503B compounding operations. In addition, they will be responsible for providing collaborative leadership over each of the key functional areas of 503B compounding including, Procurement, Pre-Production, Production, Post-Production, Laboratory and Warehouse Operations.
The VP will be responsible for working with the organization to meet company goals and objectives through planning, leading, organizing, and controlling organizational resources. They should be a doer first with the mandate, credentials and desire to act as well as train and lead. It is important that the VP operates with the highest level of integrity, collaboration and trust and is committed to upholding the Avella values.
Assist the CEO and COO in developing and building the platform for enhanced, highly-scalable, multi-site, 503B operations
Maintain operations that comply with all Federal and State regulatory agencies and internal Standard Operating Procedures (SOPs)
Execute and maintain financial, operational and customer service success of outsourcing facilities
Provide general or direct supervision to exempt employees and/or skilled non-exempt employees - Heads of each of the key functional areas - Procurement, Production, laboratory and Warehouse operations
Build provide and adhere to budgets for each of the functional areas under their supervision
Collaboratively work with the Executive Team on the establishment of new facilities and operations including – laboratory and production location operations
Collaboratively work with the Quality team to ensure Operations initiatives are consistent with regulatory requirements
Must be able to work a flexible schedule to support a multi-site, 24/7 manufacturing environment
Develop, maintain and drive key operational metrics, key performance indicators and standards to allow for the proactive management of all 503B operations
Manage workflow and staffing in 503B operations
Assist in the execution of prospect sales as required
Bachelor’s degree in pharmacy, business, or science
7 years’ experience sterile injectable manufacturing and working in high-production environments
5 years’ hands-on supervisory experience in management of production operations in a high-volume FDA regulated or pharmacy environment
Deep understanding and commitment to compliance with current Good Manufacturing Practices, all company procedures and federal and state laws, rules and regulations related to compounded medication
Knowledge and ability to apply principles and practices involved in compounding and sterile product compounding
Excellent organizational, prioritization and personnel management skills
Must be able to travel up to 50%
Lean manufacturing and Six Sigma problem solving skills
Master’s degree in Business
Experience in aseptic drug manufacturing
Strong decision-making skills with regards to financial impact, regulatory and legal issues, customer retention, patient safety and quality
Ability to work and navigate in a matrixed organization
Attributes to show strength in communication, leadership and problem-solving skills
Must be able to manage staff in all areas of facility (i.e. production, shipping/receiving, labeling/packaging, clean room, etc.)
Demonstrate the ability to work in a demanding environment and manage multiple project timelines simultaneously
Effective organizational and planning skills
Excellent communication, leadership, and team building skills
Must have the ability to prioritize and meet deadlines
Must be able to put plans on paper, lead and execute
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Job Keywords: Operations, GMP, Manufacturing, Injectables, Regulatory, Director, Leadership