Cqv, Regional Manager
1 month ago
**Job Description**:
Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Leads, mentors, trains, and manages team of compliance staff assigned to the respective regional office. Supports business development activities including sales calls, proposal writing, lead generation, etc. Tracks staff utilization and coordinates staff assignments to projects. Assists in the identification, recruiting, interviewing, and hiring of compliance staff. Maintains client relationships and responsible for overall delivery of projects in the assigned region. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. Acts as working manager and performs consulting and project assignments as required.
**KEY ACTIVITIES AND 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. Maintains contact with respective clients to assure “customer satisfaction”.
- Leads compliance service activities and oversees region specific activities for compliance consulting, commissioning, and validation.
- Supports business development strategies and activities. Includes lead generation follow-up, attending bid meetings, prepare proposals, proposal presentations, etc. Develops and maintains “industry presence” and personal network to develop opportunities.
- Promotes efficiency in staff utilization. Manages and assigns regional resources to meet project requirements. Works with other Regional Managers and other IPS disciplines to maintain targeted / budgeted utilization. Tracks staff assignments, makes resource projections, and makes necessary adjustments as required. Prepares workload forecasts to support staffing management.
- Leads, mentors, trains, and manages team of compliance staff assigned to the respective regional office. Assists and mentors staff to set performance and career goals. Provides routine feedback and conducts formal time-based performance reviews. Implements corrective action plans as required.
- Generates and performs 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”.
- Additional Job Duties and Skills:
- Leads by example. Deems the respect of upper management, peers and subordinates. Empowers staff to succeed.
- Supports and deploys 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 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 champion’s 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 Sr. Director, CQV in recruiting new staff members and promoting IPS to potential hires.
- Other duties as assigned.
Qualifications & Requirements:
**REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE**
- Bachelor’s degree in Engineering, or a related discipline or an equivalent technical degree
- A minimum of 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, Process, Computer System, Methods and other validation activities and processes.
- Detailed experience in the disci
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