Under general direction of the Vice President, Operations, responsible for assisting in the management of the Operations and Distribution groups and assuring overall cGMP compliance. Oversees all procedures affiliated with receiving, storing, packaging, distributing, returns processing and disposition of clinical supplies.
Position Reports to
Vice President, Operations
Receiving, Packaging, Distribution, Returns/Disposition, and Facilities/Materials groups
Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
- Oversees all cGMP activities related to receiving, storing, packaging, distributing, returns processing and disposition of clinical supplies.
- People Manager: Hire, train, retain and inspire existing and future Operations staff.
- Develop and maintain applicable metrics and KPIs to monitor performance relative to clinical packaging and distribution operations. Evaluate operational challenges, manage and conduct data-driven analysis to assess potential solutions, and develop strategic recommendations that address the root cause of problems. Assists and ensures that all Operations personnel follow and perform all necessary cGMP’s and Xerimis SOPs as specified.
- Assures that qualified individuals are cGMP trained to perform their respective job relative to handling and/or processing clinical supplies.
- Monitors and ensures cGMP compliance of all clinical supplies from Receipt though Distribution.
- Coordinates with Project Management to meet project timelines.
- Coordinates with Quality Assurance to maintain cGMPs and Xerimis SOP compliance within the Operations and Distribution groups.
- Coordinates all operational activities related to the processing, handling, packaging and distribution of controlled drug products, schedule III-V.
- Leads daily planning meetings.
- Assists with the creation and revision of SOP’s.
- Participates in client audits and visits as appropriate.
- Oversees the generation of, and review of, shipping documentation processing, and the processing of all shipments of clinical supplies.
- Investigates and resolves discrepancies in coordination with Quality Assurance department.
- Maintains close contact with couriers, custom brokers, and domestic and/or foreign shipping regulation organizations.
- Resources, provides analysis, and oversees sub-contracting of courier services.
- Works with the Facilities and Materials group to ensure the management of all drug product, packaging and ancillary materials and the material flow of these goods as well as the operational activities that support the maintenance of the facility and use of the equipment.
- Participates in FDA audits as needed.
- Follows documentation and confidential information procedures.
- Assures adherence to standards of personal and packaging safety.
- Other duties as required.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Related Bachelor’s degree or equivalent
- Experience in examining and re-engineering operations and procedures, formulating policy and developing and implementing new strategies and procedures.
- Familiarity with the pharmaceutical industry
- Familiarity with cGMPs
- Excellent reading and writing skills
- General mathematical skills
- Computer literacy skills
- Attention to detail
- Ability to make administrative and procedural decisions and judgments.
- Ability to foster a cooperative work environment
- Ability to plan, develop and coordinate multiple projects.
- Skill in budget preparation and fiscal management.
- Conflict resolution and/or mediation skills.
- Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this job, the employee is regularly required to talk or hear. While performing the duties of this job, the employee is exposed to an office environment and may be exposed to the warehouse and operations (packaging) environment including occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals. The noise level in the work environment is usually moderate.
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.