RESPONSIBILTIES: This position is responsible for the management of multiple small to mid-sized validation projects ensuring consistency with company strategy, commitments and goals. These projects may include elements from the following practice areas: Commissioning, Validation, and Quality Management Systems. This position will lead teams to complete all aspects of small to mid-sized commissioning and validation projects. This position will report into a Senior Validation/ Manager.
Displays the required level of proficiency in the following four areas:
- Strong technical knowledge of facility, utility, equipment, and computerized systems
- Ability to work autonomously to perform qualification activities and provide guidance to subordinates
- Work with senior management to identify the technical requirements for a project, baseline assumptions for the scope of work, and assess technical risks associated with the project
- Provide quality review and approval of validation documents (including process, equipment, computer, and method) to ensure that the documents are accurate, complete, and meet internal and external regulatory requirements such as GMP, ISO, GAMP, ISPE
- Responsible for the management of multiple client accounts generating no less than $250,000 annually
- Responsible for the sales of new client proposals targeting at no less than $150,000 with 30% gross margin
- Responsible for maintaining a minimum overall gross margin of 30% of all projects managed
- Define scopes of work, estimates project costs, reviews RFPs (Request for Proposals), and generates proposals for small to mid-sized projects
- Work with senior management to refine and finalize project costs and project performance
- Ensure adherence to project scope, deliverables, and budgets
- Develop project schedules and project plans to monitor project performance and report to client and Pharmatech Senior Leadership Team (SLT)
- Anticipate, escalate (if needed), and resolve any issues that may arise during project execution
- Prepare annual budgets, submit purchase requisitions and prepare cost benefit analysis
- Write articles, speaking engagements, and attend conferences to assist with sales and marketing of Pharmatech
- Manage resource allocation related to projects managed versus the rest of the organization for small to mid-sized projects
- Manage up to 3 direct reports with respect to their daily tasks, deliverables, and timelines; communicate on a regular basis with direct reports
- Provide direct reports with work direction, coaching, and guidance as well as provide direction for their personal career development
- Assist with the hiring and negotiation of compensation of employees and contractors
- Prepare annual reviews
- Daily interaction with client(s) to provide status updates of project deliverables, timelines, and issues
- Develops metrics to report project performance
EXPERIENCE/EDUCATIONAL REQUIREMENTS: Engineering degree preferred, B.S. in a related science is required. Qualification in Project Management/Project Management Certification is a plus. A minimum of 7 years of validation experience and/or in a related area is required (for example, QA, Manufacturing).
JOB REQUIREMENTS: Travel up to 100% may be required. Ability to lift a minimum 50 pounds and sit for extended periods of time.
SKILLS: Strong written and oral communication skills are required. Excellent technical writing skill is required. Must be proficient in Microsoft Office products, including Microsoft Project (or equivalent). Must be proficient with GDP and cGMPS. Must be motivated, possess strong leadership skills, and have the ability to work independently and function in a team environment.