Validation Manager – DPS Group – Boston, Massachusetts, USA
DPS Engineering is looking to hire an accomplished Validation Manager to support a pharmaceutical client in the Boston, MA area. This will be a full-time direct hire opportunity and this individual will have responsibilities around setting validation strategy, adhering to domestic and international GMP regulations, incorporating continuous improvements into validation activities and policies, and participating in regulatory inspections. Leadership duties will require developing strategy, leading change and motivating and developing personnel.
Duties & Responsibilities:
Develop, maintain, and deploy drug product validation policies and practices in the following areas: Facilities, Equipment, Shipping / Cold Chain, Process, Cleaning, Computer Systems, Plant Automation, and Validation Maintenance.
Develop and assess the following Quality System elements for Validation: Quality Risk Management program, CAPAs, Change Controls, Deviations, and GMP Investigations.
Develop, mentor, and coach staff.
Identify opportunities for continuous improvements, deploy best practices, pro-actively update validation programs to reflect current regulations and trends.
Ability to lead cross-functional projects individually and with dedicated staff members.
Experience in drug product validation as it pertains to managing and interacting with contract manufacturing organizations.
Bachelor’s degree in a technical, preferably an engineering or biological science or related discipline.
8+ years of pharmaceutical or biotech industry experience.
Previous leadership experience with demonstrated effectiveness in developing validation strategy, leading complex validation projects and motivating and developing personnel is preferred.
An ability to work as a team member and influence others to ensure coordinated goals are achieved.
Comprehensive knowledge of cGMP requirements and expectations as they pertain to validation.
Must be able to work with multiple individuals as part of a cross-functional team.
Must have excellent communication skills.
Must be able to work in a dynamic and fast-paced environment.