CQV Regional Manager

IPS-Integrated Project Services•Burlington, MA

2d•Hybrid

About The Position

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated CQV Regional Manager to join our talented team at our office located in Burlington, MA. In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also support business development activities, including sales calls, proposal writing, lead generation, etc. Additionally, you will track staff utilization, coordinate staff assignments to projects, and assist in the identification, recruiting, interviewing, and hiring of compliance staff.

Requirements

Bachelor’s degree in Engineering, a related discipline, or an equivalent technical degree.
10 years (Manager) to 15 years (Director) of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.
Experience with Cleaning, Processes, Computer Systems, Methods, and other validation activities and processes.
Detailed experience in the discipline of GMP/Validation with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA and international Standards and guidance (ASTM, ICH, ISPE, etc.).
Demonstrated/recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyos, autoclaves, packaging, compression/encapsulation, etc.), or by validation activity (process, cleaning, CSV, methods, etc.).

Nice To Haves

Experience with Risk-Based Approach to Commissioning and Qualification.

Responsibilities

Directly responsible for the successful delivery of compliance projects to IPS’ clients in the designated region.
Responsible for oversight of project budgets, schedules, deliverables, quality, client satisfaction, etc.
Maintain contact with respective clients to assure “customer satisfaction”.
Lead compliance service activities and oversee region-specific activities for compliance consulting, commissioning, and validation.
Support business development strategies and activities.
Develop and maintain “industry presence” and personal network to develop opportunities.
Work with the IPS CQV management team to develop and apply quality practices for all project deliverables and business practices.
In conjunction with the CQV management team, perform project audits to ensure all project goals are being met and compliance services are offered as a value-added product to IPS’ clients.
Promote efficiency in staff utilization.
Manage and assign regional resources to meet project requirements.
Work with other Regional Managers and other IPS disciplines to maintain targeted/budgeted utilization.
Track staff assignments, make resource projections, and make necessary adjustments as required.
Prepares workload forecasts to support staffing management.
Lead, mentor, train, and manage a team of compliance staff assigned to the respective regional office.
Assist and mentor staff to set performance and career goals.
Provide routine feedback and conduct formal time-based performance reviews. Implements corrective action plans as required.
Generate and perform C/Q/V deliverable activities, audits, and other compliance services as required, to meet project requirements and personal billability goals.
Works with potential new and existing clients to initiate projects following current industry practices.
Performs strategic and master planning activities to assure projects are initiated/started “on the right foot”.
Support and deploy technical training programs that assure competency and advancement levels to support corporate goals.
Maintains a high level of professionalism in validation and compliance and encourages networking, peer presentations, and involvement of self and staff in networking and educational programs.
Makes salary and compensation recommendations for regional compliance professionals and reviews the performance of local staff.
Reviews/recommends staffing additions/separations.
Performs and supports employee performance reviews.
Actively participates in relevant professional societies and pursues presentation/training opportunities.
Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champions’ technical advancement, which supports our corporate goals.
Demonstrated/recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyos, autoclaves, packaging, compression/encapsulation, etc.), or by validation activity (process, cleaning, CSV, methods, etc.).
Provide working knowledge in the delivery of technical projects in these areas.
Maintain professional conduct and deliver services in a professional and acceptable fashion.
Works in conjunction with the Senior Director, CQV, in recruiting new staff members and promoting IPS to potential hires.
Other duties as assigned.