Now Hiring - Meridian Medical Technologies, Inc. - Manager/TL - Site Change Management in Saint Louis, MO

ROLE SUMMARY

Mgr./TL-Change Management serves as the Site Champion for Change Management and is assigned as the colleague responsible for oversight of the Change Management program. The Site Change Management Process Owner (CMPO) is actively engaged in strengthening the site Change Management culture through coordinating, planning, assessing, and reporting Change Management effectiveness. This role is instrumental in developing the overall site Change Management strategy for influencing site leadership, and enhancing a Quality and EHS culture that drives to zero defects. The Mgr./TL – Change Management partners with change owners and site leadership to ensure there is a robust dialog and complete vetting process to prioritize changes at the site. The Mgr./TL – Change Management is accountable for ensuring all changes with a GMP impact are clearly documented and will satisfy a regulatory agency review.

The Mgr./TL-Change Management will ensure there is a robust, compliant and efficient process in place for the review, approval of documentation changes that have a GMP (Good Manufacturing Practices) impact at the site. This role will ensure all site changes to documentation are executed appropriately and effectively according to Site Standard Operating Procedures (SOPs), cGMP guidelines, Meridian Corporate and Regulatory requirements and the maintenance of said GMP documentation during its retention period. The scope of this role includes oversight of all changes considered to have GMP, GMP documentation, and/or validation impact, which will include a variety of functional areas within the site as well as the Record Retention Program.

ROLE RESPONSIBILITIES

Oversee/Facilitate the Site Change Control Review Committee:

• Maintain a routine schedule of meetings
• Ensure appropriate quorum is represented.
• Ensure specific individuals are invited as needed
• Call for agenda items
• Publish agenda, minutes and attendees
• Maintain a GMP record or repository of agendas and minutes.

Change Planning:

• Ensure the appropriate change planning is taking place by engaging with site stakeholders
• Implement and maintain a process by which the site can plan its GMP changes, which includes but is not limited to a change assessment, stakeholder engagement, priority scoring and a banking process for changes needing future consideration

Quality System Oversight:

• Ensure that the change management system, including documentation revisions, are fully integrated into the greater quality management system at the site (i.e., the change management process is linked to product release process, design control)
• Own and ensure a robust Change Management process for the site, through the consistent and effective use of Change Management system SOPs and tools, and strong Change Management culture across the site.
• Embrace the Meridian Change Management process by actively performing routine assessments and analysis of the site Change Management system to identify areas of risk and opportunity.
• Work with site leadership and partner with center colleagues (QSSS/TL&C/OpEx/EHS) to develop a robust site strategy and action plans for improving the Change Management system, as areas of opportunity are identified.
• Routinely query the change management system for schedule adherence/ performance
• Proactively monitor performance of the Change Management Quality System
• Communicate with change owners to ensure visibility to agreed timing
• Provide guidance on creation of clear and concise parent change records to support GMP changes.
• Provide guidance and direction related to the creation of change management action items (child records) needed to support a GMP change

Decisions/Approvals:

• Review content and approve interim reports for parent records and associated action items
• Designated representative for the Change Control Review Board, provide change management pre-approvals on behalf of the committee based on committee decision.
• Review and Approve documents associated with periodic reviews.

Metrics:

• Develop metrics that are designed to communicate the overall health of the Change Management Quality System, Document Periodic Reviews
• Review and interpret metrics and data. Determine action plans needed to maintain the Change Management Quality System in a state of compliance
• Prepare and present metrics to site leadership team

Training:

• Provides system training to user groups
• Maintains training materials

System Owner:

• Owner of the site change management Standard Operating Procedures (SOPs). Monitors changes to Pfizer and industry standards and keep site procedures current with the requirements of those standards.
• Own and ensure a robust Change Management process for the site, through the consistent and effective use of Change Management system SOPs and tools, and strong Change Management culture across the site.
• Embrace the Meridian Change Management process by actively performing routine assessments and analysis of the site Change Management system to identify areas of risk and opportunity.
• Work with site leadership and partner with center colleagues (QSSS/TL&C/OpEx/EHS) to develop a robust site strategy and action plans for improving the Change Management system, as areas of opportunity are identified.
• Change Management process subject matter expert. Represent the site during audits/ inspections.
• Quality Tracking System (QTS) System Administrator for Change Management module.
• Routinely monitors the system for user access and user privileges
• Routinely monitors system records for proper assignments (i.e., when someone leaves Meridian, records are re-assigned to appropriate colleagues)
• Develop queries/ searches to retrieve accurate information from QTS to respond to management, user or regulatory agency requests
• Maintain system/ database attributes to ensure robust future search capabilities.
• Participates in Common Interest User Group and benchmarks with other sites to leverage the power of the network and replicate best practices.
• Process owner for Documentation process and responsible for process enhancements
• Manage and maintain the review and approval systems for components, raw materials, and batch records change control program
• Ensure personnel are properly trained and provided the tools necessary to succeed
• Oversees the review and approval of site documentation that apply to product, procedures, processes, equipment, facility changes, art work, labeling and all affected systems that undergo changes
• Ensure site documents are executed appropriately by identifying and applying the appropriate sequence of required deliverables and are implemented in a systematic way to assure effective and timely closure
• Oversees the evaluation of process/procedure changes as necessary and assure document changes are implemented according to corporate, site and regulatory guidance
• Ensure Site Logbook issuance program, 200% document read for label final approval
• Act as primary document control representative for major site and corporate projects, track/trend and report to site Management staff identifying/elevating documents potentially interfering with critical path metrics
• Assist with Regulatory and Customer audits.
• Additional responsibilities as defined by Quality Management

Supervisor Responsibilities

• Provide goals and direction for personnel
• Coordinate personnel activities – i.e., vacations, sick time, etc., to ensure there is appropriate coverage in the department at all times
• Perform personnel reviews and provide immediate feedback to personnel on performance

QUALIFICATIONS

Requires Bachelor’s degree in technical field i.e. Biology, Chemistry, Engineering, Pharmacy or equivalent GMP pharmaceutical/medical device experience. The preferred candidate will have a minimum 5 years with direct involvement overseeing activities in a regulated industry.

• Knowledge of CFR Title 21 Parts 210, 211, and 820, cGMP, FDA requirements; familiarity of Part 11
• Ability to read, analyze and interpret technical procedures and government regulations. Proficient computer, proofreading, communication and customer service skills. Attention to detail
• Strong interpersonal and influential skills
• Excellent in communication and project management
• Decision-making based on a science-based risk approach.
• Communicates changes effectively; managements competing demands
• Ability to work (and lead team efforts) on multiple priorities simultaneously
• Capable of interfacing with multiple levels of people within the organization, including management, third party customers, and site colleagues
• Must be capable of organizing data from multiple sources, extracting key information to report metrics
• Experience with word-processing, spreadsheet and presentation software (e.g. Adobe Acrobat, MS Word, Excel, Access and Visio)
• Experience working in a cross-functional, matrix environment
• Independent action and sound decision-making are essential for success in the position as decisions can impact regulatory filings, product release and compliance with GMP
• Advanced analytical skills will be required to make competent decisions based on a review of analytical data. Decisions are made based upon knowledge and experience with input from the appropriate Quality Management personnel

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform mathematical calculations

Ability to perform complex data analysis

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs; sometimes exposed to loud noise.

ON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Position requires regular onsite attendance
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
• Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
• Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.
• Travel between Brentwood and Westport locations required.