Position OverviewThe Associate Manager, QA Pharmaceutical Quality Systems (PQS) supervises the PQS Document Management and Systems team for the enterprise Quality Systems administration and document control. Serving as the site Business Process Owner for quality system(s), this position is active in each system's global advisory board and acts as primary point of contact for PQS. The role applies system expertise and business knowledge, gathers recommendations for system enhancements and gaps, prioritizes and implements solutions with leadership accordingly, maintains a deep understanding of the system(s) and process functionality/improvements, and understands such improvements' local and global system(s) applications. The role also performs advanced system administration including but not limited to user management, user support, problem solving, and system training. The Associate Manager of PQS maintains relationships with site-based customers and global colleagues as well as provides updates to leadership as requested. Domestic and International travel is required.
Job DescriptionWhat You'll Do- Supervises the PQS Document Management and Systems team, ensuring allocation of adequate resources for assigned tasks, including but not limited to the quality management system (QMS) and electronic data management system (EDMS).
- Supports organization in relation to use of application(s), user access, and system support.
- Drives troubleshooting, analysis, and recommendations for process and system improvements.
- Maintains applications including support of system configuration and improvements.
- Creates and maintains application documentation and training material.
- Supports audits and inspections as subject matter expert (SME) for documentation management and PQS owned systems.
- Owns and oversees site documentation processes including document issuance, archival, and retrieval.
- Manages and develops direct reports from PQS Document Management and Systems team.
- Administers company policies such as time off, shift work, and inclement weather that directly impact employees.
- Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.).
- Coaches and guides direct reports to foster professional development.
- Participates in the recruitment process and retention strategies to attract and retain talent, as needed.
- Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution.
- Performs other duties, as assigned
Knowledge, Skills, and Abilities - Ability to coach, lead, and develop individual contributors.
- Ability to effectively present information to others.
- Flexible to support a 24/7 manufacturing facility.
- Experience in QA and/or Manufacturing within the biotech or pharmaceutical industry.
- Knowledge of GxP and regulatory requirements.
- Ability to make decisions and drive continuous improvement.
Minimum Qualifications- Bachelor's degree in related field with 5+ years of related experience; OR
- Master's degree in related field with 3+ years of related experience; OR
- PhD in related field with 1+ years of related experience.
- Experience mentoring and leading people.
- Experience working in a changing, project driven organization.
- Experience directly supporting function.
Preferred Qualifications- Experience with TracWise, Veeva.
- Experience with Document Control.
Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- Ability to sit for prolonged periods of time for up to 60 minutes.
- Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
- Ability to conduct work that includes moving objects up to 10 pounds.
- Ability to bend, push or pull, reach to retrieve materials from 18'' to 10'' in height, and use twisting motions.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
*LI-Onsite
