Quality Systems Supervisor

ROLE SUMMARY

• Site Investigation Lead
• Ensures implementation of change management system in the site.
• Site Training Lead
• Ensure Employees job performance in accordance with all applicable regulations, specifications, procedures and policies. 
• Ensures following GMP and Pfizer Standards are being followed and implemented.
• Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site.  
• Responsible for supplier qualification.

ROLE RESPONSIBILITIESSite Investigation Lead roles and responsibilities:

• Serves as LPO (Local Process Owner) for Investigation Management System & CAPA Management.
• Serves as the Site Champion for Investigations, is assigned the oversight of the Investigations program and is actively engaged in strengthening the site investigation culture through coordinating, planning, assessing, and reporting investigation effectiveness in line with the Investigations One Best Way.
• This role is instrumental in developing the overall site investigations strategy for reducing repeat manufacturing and safety investigations/incidents, influencing site leadership, and enhancing a Quality and EHS culture that drives to zero defects.  Depending on the site, this role may require 50-100% of a colleague’s time.
• Prioritizing investigations related to AQRT issues”.
• Responsible for preparing the “Area Quality Review Team Reports” for issues/ Complaints / Market action that require AQRT attention.
• Share in the preparation of the issues that require SQRT attention. 

Site Investigation System and Strategy

• Own and ensure a robust investigation process for the site, through the consistent and effective use of investigation system SOP/s and tools, and strong investigation culture across the site.  
• Embrace the “one best way” philosophy by actively performing routine assessments and analysis of the site investigation system through the use of the Investigation Utilization Tool and the Investigation Maturity Scale, analyzing related metrics, seeking out trends and discussing opportunities regularly at the SQRT and/or SLT meetings. 
• 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 Investigation system, as areas of opportunity are identified. 

Capability Building and Site Collaboration 

• Implement the Global Investigations Training Curricula for QO and EHS investigations; ensure ongoing support, active coaching, and the use of the structured on-the-job documents for qualification of new originators/investigators/approvers and for those that may need additional knowledge and skills. Work with Center resources as necessary. 
• Ensure sufficient training and coaching resources are available and occur in a timely manner to meet site investigation goals. 
• Collaborate with the site PHP Lead, site training lead, site OE colleague, site EHS colleagues to ensure that all investigations training, tools and methodology are consistently used, including DMAIC methodology (M1/M2/M3) to ensure adequate RC analysis and CAPA, and PHP to reduce and prevent Human Error.

Global Investigation Sharing

• Participate regularly and contribute to global discussion groups (PHPCIG, MINE meeting, ASK-MINE, others) sharing information between the groups and the site colleagues, replicating practices, and promoting/enabling site colleague participation. 
• Work as needed with QS&C (QSSS/TL&C), OpEx and EHS SME’s to keep up to date with activities regarding the Investigations system. 
• Collaborate as needed (along with site PHP Lead) with the Regional PHP Lead 
• Work closely with QTS MIR/LIR/CITI User Council Representatives to identify opportunities for system improvements, review proposed updates, and communicate planned changes to site QTS users.

Change Management System:

• Serves as LPO (Local Process Owner) for Change Management system.
• System owner for Change control system at KAEC site including relevant Quality Management System change control module. 
• Complete and follow up on all required impact assessment and approval of change control requests in KAEC site (e.g. manufacturing changes, supplier changes, material changes and any GMP related changes).

Supplier Qualification:

• Serves as LPO (Local Process Owner) for Supplier Qualification & Management.
• Establishment of supplier qualification system. 
• External auditing on local suppliers of incoming materials (prepare annual plan of external audits with procurement & Quality Control departments, audit execution and documentation and follow up with suppliers for closure of non-conformities). 
• Establishment and maintenance of Contractors & Suppliers Oversight approach. 
• Ensuring the ongoing monitoring program is effective.   
• Prepare quality agreement with applicable suppliers, contractors & service providers. 

Product Complaints:

• Serves as LPO (Local Process Owner) for Complaints Management System.
• Quality related product complaints investigation review and approval.
• Responsible for preparing the “Area Quality Review Team Reports” for issues/ Complaints / Market action that require AQRT attention.
• Share in the preparation of the issues that require SQRT attention. 

Market Action:

• Serves as LPO (Local Process Owner) for Market Action Management.
• Responsible to maintain the system in KAEC site.
• Provide all required data and product details to Quality Affiliate.  
• Responsible for preparing the “Area Quality Review Team Reports” for issues/ Complaints / Market action that require AQRT attention.
• Share in the preparation of the issues that require SQRT attention. 

Personnel & Training Managment (P&TM):

• Serves as LPO (Local Process Owner) for P&TM.
• System owner for PLA system at KAEC site.  
• Maintain a Compliant Training Quality System. 
• Ensure that local procedures comply with PQS (Pfizer Quality Standards) and meet all local regulatory requirements. 
• Ensure that all elements of the Training Quality System are maintained compliantly, including: GMP Training Materials, GMP Training, Learning Assessments, Orientation Training, Trainers, Training Curricula, Training Methodology, Training Records & Training System Metrics.
• Partner with Department Supervisors and Managers to ensure that training curricula are developed and maintained for all GMP activities and that Training Curricula contain all necessary training for independent performance of the related GMP activities. 
• Partner with Department Supervisors and Managers to ensure that Training Curricula are deployed in a timely manner to all colleagues and contingent workers performing GMP activities in the department/area.  
• Define the process for the control and update of Training Curricula and implement the process for periodic review of Training Curricula. 
• Define which training topics require periodic retraining/requalification and implement effectively. 
• Support Department Supervisors to accurately determine their team/colleagues training status prior to assigning GMP tasks to colleagues and contingent workers. 
• Ensure that effective Orientation Training programs are in place (Basic, Additional, departments/areas). 
• Ensure that training records are completed appropriately and maintained according to Pfizer record retention policies, including the specific records related to consultants (if needed). 
• Ensure that PLA (Pfizer Learning Academy) or manual tracking system is properly maintained for training requirements (Curricula) and training records (training history and qualifications). 
• Ensure that training methodology and the need for a learning assessment is determined via a documented risk analysis and effectively implemented for all SOPs. 
• Ensure that GMP Refresher Training is conducted annually, with topics being determined by analyzing relevant needs for the site/location and ensuring that the training is relevant to colleagues’ roles and responsibilities. 
• Maintain current knowledge of regulatory requirements and cGMP expectations for training. 
• Where appropriate, lead site training team; coach and develop team members to ensure flexibility of operations and improve engagement and individual development / growth to optimize training skills.  
• Develop and communicate site training objectives annually and share with SQRT (Site Quality Review Team) for endorsement and feedback. 
• Where appropriate, conduct an annual review of the site Training System (Periodic Training Review)  
• Develop an Annual Training Plan that includes required GMP training, as well as other topics.

Delegate for SOPs Quality Approval:

• Delegate for QA Manager
• Member in internal audit team & due diligence audits.
• Member in internal audit team & due diligence audits.

Back up for the following Systems:

• Planning, execution and reporting of validation / qualification activities.
• Creation, review, or approval of process, hold time & packaging validation protocols andreports.
• Creation, review or approval of Cleaning Validation protocols and reports.
• Creation, review or approval of Equipment, Systems & utilities qualification protocols and reports.
• Development of relevant Validation Master Plans and SOPs.
• Review/Approval of other Validation Protocols and Reports (e.g. commissioning, Computerized System Validation).
• Development of relevant Validation Master Plans and SOPs.
• Validation Periodic Review.
• Continued/Ongoing Process, Cleaning & Packaging Verification.

Document Control: 

• Establishment and maintenance of document control system.
• Management of Pfizer Document Management System: Act as a Document Class Manager responsible for routing documents for review and approval.

Periodic Product Review:

• Review & approval of risk assessments for annual review plan. 
• Supervise annual product review plan execution.
• Review and approval of annual product reviews, assigning any corresponding actions.

BASIC QUALIFICATIONS:

• 5+ Years of experience in Quality Assurance role.
• Ability to work independently and with work teams.
• Management and decision making skills.
• Communication & high interpersonal skills.
• Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
• Good Command of English both written and spoken
• High analytical skills. 
• Strong interpersonal and influential skills
• Excellent in communication and project management 
• Decision-making based on a risk science based approach
• Willing to embrace innovation and change in order to find solutions.
• Logic way of thinking.

PREFERRED QUALIFICATIONS:

• Trained on QAR investigator curricula
• Certified Train the Trainer
• PHP – Foundations and PHP – Putting it to Work 
• Quality Risk Management (QRM)
• M1 (yellow belt certified), M2
• Experience with relevant QTS modules
• Project Manager, team leader/project leader and coach
• Committed to the Investigations One Best Way to enable QAR reduction and a general improvement of the Investigations System

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