Training & Documentation Compliance Manager

工作内容

Our manufacturing logistics and supply team makes sure that customers and patients have the medicines they need, when they need them. You’ll help bring medicines to the world even faster by embracing challenges, imagining what’s possible and taking action.JOB FOCUSThe IO Training & Documentation Compliance Team is responsible for implementation, operations and maintenance of the technical training and procedural documentation processes within Intercompany Operations (IO), SCESQ IO Quality (GDP), manages new learner training requirements and SAP Access.The Training and Documentation Compliance Manager works closely with Quality & Compliance Leadership and all functional business owners in IO as a strategic business partner with in-depth knowledge of the business, projects and best practices in training and documentation. The Manager is responsible for leading, planning and executing training and documentation strategies to increase the effectiveness and technical knowledge of IO colleagues, enabling them to perform their job duties at an elevated level.This role drives continuous improvement initiatives, collaboration and decision-making across IO functions and key stakeholders to provide the best experience for learners, document authors, trainers, and managers while safeguarding compliance requirements and ensuring that critical documentation is maintained and available during internal or external inspections.This role will act as IO Training Lead and is responsible for oversight, effective management, and sustainability of the training system. This role also reports on the status of the training system as required, including Site Quality Review Meetings.As SAP Compliance Lead for all Global Logistics Positions, this role is key to ensuring SOD conflicts are mitigated, SAP access is approved for all IO colleagues, monthly controls are performed and approved in PC Tool, and Intercompany Fire Fighter Logs are reviewed and approved.Job SummaryPeople Management (20%)

• Lead, motivate, and coach the Training and Documentation team in the execution of operational objectives
• Build an effective team structure and ensure necessary resources and tools are available for optimal team performance & colleague well-being
• Establish an overall talent growth and succession plan for team members
• Assist and provide expertise to the team to support adequate decision making
• Manage complex and escalated issues in conjunction with the team to ensure compliance while developing and encouraging team growth

Day-to-Day Supervision (40%)

• Develop operating structures to ensure documentation & training solutions meet quality, business and end-user requirements including easy access to information and effective issue resolution
• Monitor IO performance and adherence to Training & Documentation process, standards and compliance and ensure accurate reporting process for gaps to required teams and the appropriate IO IMEX Tier level
• Guarantee execution of operational activities in line with required timelines and using appropriate processes, while adhering to and remaining compliant with department, local and/or Pfizer Global procedures
• Act as the prime interlocutor and first level of escalation for the Senior Training & Documentation Compliance Specialists on all topics, issues, and questions in relation to their area of responsibility
• Report and escalate issues and/or non-compliance events to appropriate levels of Leadership as required
• Ensure core capabilities are adequately staffed including holiday periods and that an adequate back-up plan is in place
• Ensure all relevant SOP/WI are in place and reviewed in a timely manner
• Act as the IO Training and Documentation SME during on-site audits (internal and external) and provide requested data and/or information regarding the IO Training and Documentation process

Training Lead (40%)

• Develop training programs based on training needs analysis and ensure adequate training methods are organized for “business as usual”, continuous improvements and as required by change management for impacted colleagues
• Identify the appropriate implementation approach through the effective use of training capacities, SMEs, and buddies
• Partner with IOmanagement and stakeholders to identify areas where new and/or improved training initiatives can add value to transformIO’s performance
• Support stakeholders to develop training curricula that match skills requirements based on Role Profiles

KEY PERFORMANCE INDICATORS (KPI)

• Level of training of IO and IO Quality GDP
• No overdue CAPA actions
• No missing documentation and training evidence during internal/external inspections
• Timely creation and availability of all audit and operational reports
• Documentation and training rolled out within defined due dates
• Meet agreed upon departmental and individual objectives
• Works according to relevant SOP / WI

About This Role

• This is a people manager role.
• Possible location: Zaventem (Belgium). For this position we do not offer relocation.

QualificationsLevel of Education:

• Master’s in Administration or equivalent by experience

Experience:

• +5 years’ experience in pharmaceutical industry and/or relevant industries in similar or complimentary role.
• Knows the principles of Quality Management and Quality Training Systems and is proficient in Good Documentation Practices, Data Integrity, and ALCOA principles.
• Experience in applied GDP, training concepts and adult learning principles.
• Familiar with audit and inspection behaviors as an SME for Training, Documentation and Financial elements linked to SAP access and SODs.

Languages:

• Fluent in English (required)

COMPETENCIESNetworking and collaboration:

• Able to build and maintain successful working relationships with internal customers in IO, GSC, PGS and other stakeholders in the Pfizer network. Creates an expanded network of related functions and colleagues in more senior level positions. Quickly finds common ground and tries to solve problems for all. Responds and relates well to peers and colleagues at all levels. Is a team player and cooperative.

Change Agility:

• Proactively identifies and learns new skills to increase performance, driving self-improvement as part of long-term career aspirations. Embraces organizational change and helps others to adapt and thrive from such changes. Seeks to go beyond standard knowledge.

Risk Management and Problem Solving:

• Able to interpret / analyze data and draw conclusions; capable of business problem solving with larger value and greater complexity. Uses a combination of logic, analysis, experience, and proven methods (ie. how a similar problem may have been resolved in the past, understand past successes/failures, etc.) to make sound, timely decisions and to solve problems. Demonstrates advanced skill and insight in gathering and sorting key information and drawing meaningful conclusions to propose value-added solutions. Is well respected and sought out often by peers and leaders for input, process support and direction. Ability to identify and resolve risks or issues that would hinder progress and drive a mitigation plan to address.

Negotiation & Influencing skills:

• Achieves operational objectives that require negotiation/ influencing of senior colleagues of own and customer functions, often with outcomes that conflict with stakeholder goals. Ability to draw the big picture and set the context, using tactics beyond logic and reason to persuade stakeholders. Prepares and drives difficult conversations with senior leadership within function and with customer functions.

OUR OFFERAt Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence.Our breakthrough culture lends itself to our dedication to transforming millions of lives. Pfizer’s open-door policy is an integrated part of our culture across all levels of seniority.We offer possibilities for working from home (up to 3 days per week) and flexible working hours.Competitive salaries and benefit packages: DKV hospitalisation, outpatient, life and disability insurance, pension plan, in-company restaurant, phone, public transport reimbursement, …Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments…Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story.Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research centers in the world, 2)Elsene, the Belgian headquarters, 3)Puurs, Pfizer’s production and packaging site, and 4) Zaventem, the international Pfizer’s Logistics Center.More information can be found atwww.pfizer.com,www.pfizer.beand on Facebook and Twitter.Logistics & Supply Chain Mgmt